Heart Failure With Reduced Ejection FractionPhase 3PARADIGM-HFNCT01035255
This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure
A Phase 3 study testing LCZ696 200 mg BID and Enalapril 10 mg BID in people with Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 1,031 sites in 47 countries.
Trial summary
The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- LCZ696 200 mg BID and Enalapril 10 mg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,442 participants
- Where
- 1,031 sitesin 47 countries
- Study dates
- Dec 2009to May 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must give written informed consent before any assessment is performed.
- Outpatients ≥ 18 years of age, male or female.
- Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =< 35%) and elevated BNP.
- Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
- Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
Who cannot join
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
- Previous history of intolerance to recommended target doses of ACEIs or ARBs
- Known history of angioedema.
- Requirement of treatment with both ACEIs and ARBs.
- Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
Show all 10Show fewer
- Symptomatic hypotension and/or a SBP < 100 mmHg.
- Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula
- Serum potassium > 5.2 mmol/L.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1,031 sites in 47 countries.
1031 sites in 47 countries
United States155 sites
Novartis Investigative Site
Albuquerque, New Mexico, 87102
Novartis Investigative Site
Alexandria, Louisiana, 71301
Novartis Investigative Site
Aliquippa, Pennsylvania, 15001
Novartis Investigative Site
Amarillo, Texas, 79106
Novartis Investigative Site
Anaheim, California, 92801
Novartis Investigative Site
Anchorage, Alaska, 99508
Novartis Investigative Site
Ann Arbor, Michigan, 48106
Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Asheboro, North Carolina, 27204
Novartis Investigative Site
Asheville, North Carolina, 28803
Novartis Investigative Site
Ayer, Massachusetts, 01432
Novartis Investigative Site
Baltimore, Maryland, 21208
Novartis Investigative Site
Bartlesville, Oklahoma, 74006
Novartis Investigative Site
Beaumont, Texas, 77701
Novartis Investigative Site
Beaumont, Texas, 77702
Novartis Investigative Site
Beaver, Pennsylvania, 15009
Novartis Investigative Site
Bellflower, California, 90706
Novartis Investigative Site
Beltsville, Maryland, 20705
Novartis Investigative Site
Berkley, California, 94705
Novartis Investigative Site
Biddeford, Maine, 04005
Novartis Investigative Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Birmingham, Alabama, 35211
Novartis Investigative Site
Boston, Massachusetts
Novartis Investigative Site
Boynton Beach, Florida, 33472-2952
Novartis Investigative Site
Brownsville, Texas, 78520
Novartis Investigative Site
Cadiz, Ohio, 43907
Novartis Investigative Site
Canton, Ohio, 44710
Novartis Investigative Site
Cary, North Carolina, 27511
Novartis Investigative Site
Charleston, South Carolina, 29401-5799
Novartis Investigative Site
Chicago, Illinois, 60612
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Cincinnati, Ohio, 45267-0585
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigative Site
Columbus, Ohio, 43210
Novartis Investigative Site
Cordtlandt Manor, New York, 10567
Novartis Investigative Site
Covington, Georgia, 30014
Novartis Investigative Site
Covington, Louisiana, 70433
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Dallas, Texas, 75235
Novartis Investigative Site
Dallas, Texas, 75251
Novartis Investigative Site
Dallas, Texas, 75390
Novartis Investigative Site
Davie, Florida, 33324
Novartis Investigative Site
Decatur, Georgia, 30030
Novartis Investigative Site
Denver, Colorado, 80206
Novartis Investigative Site
Denver, Colorado, 80220
Novartis Investigative Site
Des Moines, Iowa, 50314
Novartis Investigative Site
Detroit, Michigan, 48202
Novartis Investigative Site
Elizabeth, New Jersey, 07202
Novartis Investigative Site
Fort Lauderdale, Florida, 33316
Novartis Investigative Site
Fredericksburg, Virginia, 22401
Novartis Investigative Site
Fremont, Nebraska, 68025
Novartis Investigative Site
Gainesville, Florida, 32608
Novartis Investigative Site
Gilbert, Arizona, 85234
Novartis Investigative Site
Grand Island, Nebraska, 68803
Novartis Investigative Site
Grapevine, Texas, 76051
Novartis Investigative Site
Greensboro, North Carolina, 27401
Novartis Investigative Site
Hamilton, New Jersey, 08690
Novartis Investigative Site
Haverhill, Massachusetts, 01830
Novartis Investigative Site
Honolulu, Hawaii, 96813
Novartis Investigative Site
Honolulu, Hawaii, 96817
Novartis Investigative Site
Houston, Texas, 77024
Novartis Investigative Site
Houston, Texas, 77025
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Houston, Texas, 77070
Novartis Investigative Site
Houston, Texas, 77081
Novartis Investigative Site
Huntsville, Alabama, 35801
Novartis Investigative Site
Jacksonville, Florida, 32209-6511
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Jacksonville, Florida, 32223
Novartis Investigative Site
Kingwood, Texas, 77339
Novartis Investigative Site
Lafayette, Louisiana, 70501
Novartis Investigative Site
Lakeland, Florida, 33805
Novartis Investigative Site
Lapeer, Michigan, 48446
Novartis Investigative Site
Laurelton, New York, 11422
Novartis Investigative Site
Layton, Utah, 84041
Novartis Investigative Site
Leesburg, Florida, 34748
Novartis Investigative Site
Little Rock, Arkansas, 72204
Novartis Investigative Site
Little Rock, Arkansas, 72205
Novartis Investigative Site
Livingston, Texas, 77351
Novartis Investigative Site
Loma Linda, California, 92357
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
Los Angeles, California, 90073
Novartis Investigative Site
Lufkin, Texas, 75904
Novartis Investigative Site
Madison, Wisconsin, 53792-1615
Novartis Investigative Site
Marion, Ohio, 43302
Novartis Investigative Site
Mather, California, 95655
Novartis Investigative Site
Maywood, Illinois, 60153
Novartis Investigative Site
Melrose Park, Illinois, 60160
Novartis Investigative Site
Memphis, Tennessee, 38104
Novartis Investigative Site
Milwaukee, Wisconsin, 53295
Novartis Investigative Site
Minneapolis, Minnesota, 55417
Novartis Investigative Site
Mobile, Alabama, 36608
Novartis Investigative Site
Muscle Shoals, Alabama, 35662
Novartis Investigative Site
Nashua, New Hampshire, 03060
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
Nashville, Tennessee, 37212
Novartis Investigative Site
Natick, Massachusetts, 01760
Novartis Investigative Site
New Brunswick, New Jersey, 08901
Novartis Investigative Site
New York, New York, 10032
Novartis Investigative Site
Newark, New Jersey, 07103-2714
Novartis Investigative Site
Northport, New York, 11768
Novartis Investigative Site
Nottingham, Maryland, 21236
Novartis Investigative Site
Ocean City, New Jersey, 07712
Novartis Investigative Site
Oceanside, California, 92056
Novartis Investigative Site
Odessa, Texas, 79761
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104
Novartis Investigative Site
Oklahoma City, Oklahoma, 73120
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Palm Springs, California, 92262
Novartis Investigative Site
Park Ridge, Illinois, 60068
Novartis Investigative Site
Philadelphia, Pennsylvania, 19102-1192
Novartis Investigative Site
Phoenix, Arizona, 85006
Novartis Investigative Site
Phoenix, Arizona, 85020
Novartis Investigative Site
Picayune, Mississippi, 39466
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15206
Novartis Investigative Site
Plano, Texas, 75024
Novartis Investigative Site
Pomona, California, 91767
Novartis Investigative Site
Port Charlotte, Florida, 33952
Novartis Investigative Site
Portland, Oregon, 97239-3098
Novartis Investigative Site
Pratt, Kansas, 67124
Novartis Investigative Site
Quincy, Illinois, 62301
Novartis Investigative Site
Raleigh, North Carolina, 27610
Novartis Investigative Site
Rapid City, South Dakota, 57701
Novartis Investigative Site
Richmond, Virginia, 23219
Novartis Investigative Site
Richmond, Virginia, 23249
Novartis Investigative Site
Rolling Fork, Mississippi, 39159
Novartis Investigative Site
Sacramento, California, 95816
Novartis Investigative Site
Saginaw, Michigan, 48601
Novartis Investigative Site
Saint Paul, Minnesota, 55102
Novartis Investigative Site
San Diego, California, 92103
Novartis Investigative Site
San Diego, California, 92161
Novartis Investigative Site
Santa Rosa, California, 95405
Novartis Investigative Site
Seattle, Washington, 98103
Novartis Investigative Site
Slidell, Louisiana, 70458
Novartis Investigative Site
South Portland, Maine, 04106
Novartis Investigative Site
Spokane, Washington, 99204
Novartis Investigative Site
Springfield, Missouri, 65804
Novartis Investigative Site
Springfield, Missouri, 65807
Novartis Investigative Site
Stamford, Connecticut, 06905
Novartis Investigative Site
Stillwater, Oklahoma, 74074
Novartis Investigative Site
Stockton, California, 95204
Novartis Investigative Site
Tacoma, Washington, 98405
Novartis Investigative Site
Tamarac, Florida, 33321
Novartis Investigative Site
Tampa, Florida, 33609
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Tulsa, Oklahoma, 74104-4243
Novartis Investigative Site
Tulsa, Oklahoma, 74136
Novartis Investigative Site
Tustin, California, 92780
Novartis Investigative Site
Tyler, Texas, 75701
Novartis Investigative Site
Washington D.C., District of Columbia, 20422
Novartis Investigative Site
Waukesha, Wisconsin, 53188
Novartis Investigative Site
Wausau, Wisconsin, 54401
Novartis Investigative Site
Wichita, Kansas, 67207
Novartis Investigative Site
Wilmington, North Carolina, 28401
Germany104 sites
Novartis Investigative Site
Ahrensfelde, 16356
Novartis Investigative Site
Bad Homburg, 61348
Novartis Investigative Site
Bad Krozingen, 79189
Novartis Investigative Site
Bad Salzuflen, 32105
Novartis Investigative Site
Bad Schwartau, 23611
Novartis Investigative Site
Barsinghausen, 30890
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Berlin, 10115
Novartis Investigative Site
Berlin, 10369
Novartis Investigative Site
Berlin, 10559
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 13055
Novartis Investigative Site
Berlin, 13347
Novartis Investigative Site
Berlin, 13509
Novartis Investigative Site
Berlin, 14050
Novartis Investigative Site
Bernau, 16321
Novartis Investigative Site
Bitburg, 54634
Novartis Investigative Site
Bremen, 28277
Novartis Investigative Site
Buch, 13125
Novartis Investigative Site
Chemnitz, 09130
Novartis Investigative Site
Darmstadt, 64287
Novartis Investigative Site
Dessau, 06846
Novartis Investigative Site
Dietzenbach, 63128
Novartis Investigative Site
Dortmund, 44137
Novartis Investigative Site
Dresden, 01099
Novartis Investigative Site
Dresden, 01127
Novartis Investigative Site
Dresden, 01129
Novartis Investigative Site
Dresden, 01309
Novartis Investigative Site
Eilenburg, 04838
Novartis Investigative Site
Elsterwerda, 04910
Novartis Investigative Site
Erfurt, 99084
Novartis Investigative Site
Frankfurt, 60488
Novartis Investigative Site
Frankfurt, 65929
Novartis Investigative Site
Georgsmarienhütte, 49124
Novartis Investigative Site
Giengen an der Brenz, 89537
Novartis Investigative Site
Goch, 47574
Novartis Investigative Site
Graben-Neudorf, 76676
Novartis Investigative Site
Hamburg, 21075
Novartis Investigative Site
Hamburg, 22041
Novartis Investigative Site
Hamburg, 22291
Novartis Investigative Site
Hamburg, 22527
Novartis Investigative Site
Hamburg, 22765
Novartis Investigative Site
Hamminkeln, 46499
Novartis Investigative Site
Hanover, 30165
Novartis Investigative Site
Heidelberg, 69115
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Hoppegarten-Dahlwitz, 15366
Novartis Investigative Site
Huy / OT Anderbeck, 38836
Novartis Investigative Site
Ingelheim, 55218
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Jena, 07743
Novartis Investigative Site
Kallstadt, 67169
Novartis Investigative Site
Kassel, 34121
Novartis Investigative Site
Kassel, 34125
Novartis Investigative Site
Kassel, 34127
Novartis Investigative Site
Kelkheim, 65779
Novartis Investigative Site
Köthen, 06366
Novartis Investigative Site
Künzelsau, 74653
Novartis Investigative Site
Langen, 63225
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04109
Novartis Investigative Site
Leipzig, 04129
Novartis Investigative Site
Leipzig, 04315
Novartis Investigative Site
Leipzig, 04357
Novartis Investigative Site
Löhne, 32584
Novartis Investigative Site
Lübeck, 23558
Novartis Investigative Site
Ludwigshafen, Germany, 67061
Novartis Investigative Site
Ludwigshafen, 67067
Novartis Investigative Site
Lütjenburg, 24321
Novartis Investigative Site
Mainz, 55116
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68305
Novartis Investigative Site
Mannheim, 68165
Novartis Investigative Site
Meissen, 01662
Novartis Investigative Site
Meißen, 01662
Novartis Investigative Site
Mönchengladbach, 41063
Novartis Investigative Site
Mühldorf, 84453
Novartis Investigative Site
Mühlheim, 45468
Novartis Investigative Site
München, 80336
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Neunkirchen, 57290
Novartis Investigative Site
Neunkirchen, 66539
Novartis Investigative Site
Nienburg, 31582
Novartis Investigative Site
Offenbach, 63073
Novartis Investigative Site
Oldenburg i.H., 23758
Novartis Investigative Site
Osnabrück, 49080
Novartis Investigative Site
Papenburg, 26871
Novartis Investigative Site
Rhaunen, 55624
Novartis Investigative Site
Riesa, 01589
Novartis Investigative Site
Rodgau, 63110
Novartis Investigative Site
Saint Ingbert - Oberwuerzbach, 66386
Novartis Investigative Site
Schenklengsfeld, 36277
Novartis Investigative Site
Schkeuditz, 04435
Novartis Investigative Site
Schwäbisch Hall, 74523
Novartis Investigative Site
Unterschneidheim, 73485
Novartis Investigative Site
Wangen, 88239
Novartis Investigative Site
Wardenburg, 26203
Novartis Investigative Site
Weeze, 47652
Novartis Investigative Site
Wermsdorf, 04779
Novartis Investigative Site
Westhofen, 67593
Novartis Investigative Site
Wetzlar-Naunheim, 35584
Novartis Investigative Site
Weyhe, 28844
Novartis Investigative Site
Wolmirstedt, 39326
Russia71 sites
Novartis Investigative Site
Gatchina, 188300
Novartis Investigative Site
Ivanovo, 153012
Novartis Investigative Site
Izhevsk, 426063
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Kemerovo, 650002
Novartis Investigative Site
Kemerovo, 650029
Novartis Investigative Site
Kemerovo, 650099
Novartis Investigative Site
Kirov, 610027
Novartis Investigative Site
Krasnodar, 350012
Novartis Investigative Site
Krasnodar, 350086
Novartis Investigative Site
Moscow, 101990
Novartis Investigative Site
Moscow, 105203
Novartis Investigative Site
Moscow, 105229
Novartis Investigative Site
Moscow, 109240
Novartis Investigative Site
Moscow, 111539
Novartis Investigative Site
Moscow, 115280
Novartis Investigative Site
Moscow, 115487
Novartis Investigative Site
Moscow, 115516
Novartis Investigative Site
Moscow, 117198
Novartis Investigative Site
Moscow, 117556
Novartis Investigative Site
Moscow, 119333
Novartis Investigative Site
Moscow, 119881
Novartis Investigative Site
Moscow, 119992
Novartis Investigative Site
Moscow, 121309
Novartis Investigative Site
Moscow, 121552
Novartis Investigative Site
Moscow, 125284
Novartis Investigative Site
Moscow, 127473
Novartis Investigative Site
N.Novgorod, 603005
Novartis Investigative Site
N.Novgorod, 603073
Novartis Investigative Site
Nizhny Novgorod, 603003
Novartis Investigative Site
Nizhny Novgorod, 603126
Novartis Investigative Site
Novosibirsk, 630051
Novartis Investigative Site
Novosibirsk, 630087
Novartis Investigative Site
Novosibirsk-117, 630117
Novartis Investigative Site
Orenburg, 460000
Novartis Investigative Site
Orenburg, 460040
Novartis Investigative Site
Penza, 440026
Novartis Investigative Site
Perm, 614097
Novartis Investigative Site
Petrozavodsk, 185019
Novartis Investigative Site
Rostov-on-Don, 344022
Novartis Investigative Site
S-Petersburg, 191144
Novartis Investigative Site
S.-Petersburg, 194354
Novartis Investigative Site
S.-Petersburg, 198205
Novartis Investigative Site
Saint Petersburg, 193163
Novartis Investigative Site
Saint Petersburg, 194017
Novartis Investigative Site
Saint Petersburg, 194044
Novartis Investigative Site
Saint Petersburg, 194295
Novartis Investigative Site
Saint Petersburg, 195067
Novartis Investigative Site
Saint Petersburg, 196084
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saint Petersburg, 197119
Novartis Investigative Site
Saint Petersburg, 197341
Novartis Investigative Site
Saint Petersburg, 198013
Novartis Investigative Site
Saint Petersburg, 199106
Novartis Investigative Site
Samara, 443070
Novartis Investigative Site
Samara, 443095
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Saratov, 410028
Novartis Investigative Site
Smolensk, 214018
Novartis Investigative Site
St-Peterburg, 190000
Novartis Investigative Site
Syktyvkar, 167981
Novartis Investigative Site
Tula, 300053
Novartis Investigative Site
Tver', 170036
Novartis Investigative Site
Vladimir, 600020
Novartis Investigative Site
Volgograd, 400008
Novartis Investigative Site
Voronezh, 394065
Novartis Investigative Site
Yaroslavl, 150003
Novartis Investigative Site
Yaroslavl, 150062
Novartis Investigative Site
Yekaterinburg, 620028
Novartis Investigative Site
Yekaterinburg, 620102
Novartis Investigative Site
Yekaterinburg, 620137
Argentina54 sites
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1090AAH
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1209ABD
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1405BCH
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1426EGR
Novartis Investigative Site
Buenos Aires, Buenos Aires
Novartis Investigative Site
Buenos Aires, San Juan Province
Novartis Investigative Site
Caba, Buenos Aires, C1221ADC
Novartis Investigative Site
Caba, Buenos Aires, C1425DTG
Novartis Investigative Site
Caba, Buenos Aires F.D., C1179AAB
Novartis Investigative Site
Caba, Buenos Aires F.D., C1425FVH
Novartis Investigative Site
Cipolletti, Río Negro Province, 8324
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN
Novartis Investigative Site
Córdoba, Córdoba Province, 5000
Novartis Investigative Site
Córdoba, Córdoba Province, X5000AAW
Novartis Investigative Site
Córdoba, Córdoba Province, X5000AAX
Novartis Investigative Site
Córdoba, Córdoba Province, X5000BSQ
Novartis Investigative Site
Córdoba, Córdoba Province, X5003DCP
Novartis Investigative Site
Córdoba, Córdoba Province, X5006IKK
Novartis Investigative Site
Córdoba, Córdoba Province, X5009BSN
Novartis Investigative Site
Córdoba, Córdoba Province, X5014OPO
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KEH
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KET
Novartis Investigative Site
Corrientes, Corrientes Province, W3400CLH
Novartis Investigative Site
Corrientes, Corrientes Province, W3400
Novartis Investigative Site
Formosa, Formosa Province, P3600
Novartis Investigative Site
Formosa, Formosa Province, P3634XAR
Novartis Investigative Site
Lanus, Buenos Aires, B1824ABE
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600DHK
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600FZD
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600FZN
Novartis Investigative Site
Mendoza, Mendoza Province, M5500AAJ
Novartis Investigative Site
Mendoza, Mendoza Province, M5500CHC
Novartis Investigative Site
Mendoza, Mendoza Province, M5500EOB
Novartis Investigative Site
Munro, Buenos Aires, B1605DSX
Novartis Investigative Site
Pilar, Buenos Aires, B1629AHJ
Novartis Investigative Site
Quilmes, Buenos Aires, B1878DVB
Novartis Investigative Site
Rosario, Santa Fe Province, 2000
Novartis Investigative Site
Rosario, Santa Fe Province, S2000AII
Novartis Investigative Site
Rosario, Santa Fe Province, S2001SBL
Novartis Investigative Site
Rosario, Santa Fe Province, S2002KDS
Novartis Investigative Site
Rosario, Santa Fe Province, S200CXP
Novartis Investigative Site
Salta, Salta Province, A4400ANG
Novartis Investigative Site
San Isidro, Buenos Aires, B1642DJG
Novartis Investigative Site
San Juan, San Juan Province, J5402DIL
Novartis Investigative Site
San Luis, San Luis Province, D5702JRS
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000EBR
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000IIH
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000JCU
Novartis Investigative Site
San Salvador de Jujuy, Jujuy Province, Y4600ABF
Novartis Investigative Site
Santa Fe, Santa Fe Province, S3000EOZ
Novartis Investigative Site
Santa Fe, Santa Fe Province, S3000FWO
Novartis Investigative Site
Santiago del Estero, Santiago del Estero Province, G4200AQK
Novartis Investigative Site
Trelew, Chubut Province, U9100AQR
Novartis Investigative Site
Zárate, Buenos Aires, 2800
United Kingdom49 sites
Novartis Investigative Site
Basingstoke, Hampshire, RG24 9NA
Novartis Investigative Site
Birmingham, B18 7QH
Novartis Investigative Site
Blackpool, FY3 8NR
Novartis Investigative Site
Bournemouth, BH7 7DW
Novartis Investigative Site
Bradford, BD9 6RJ
Novartis Investigative Site
Brighton, East Sussex, BN2 5BE
Novartis Investigative Site
Bristol, Bs2 8hw
Novartis Investigative Site
Cambridge, Cambrigdeshire, CB2 0QQ
Novartis Investigative Site
Cheshire, CW1 4QJ
Novartis Investigative Site
Coventry, CV2 2DX
Novartis Investigative Site
Craigavon, Northern Ireland, BT63 5QQ
Novartis Investigative Site
Croydon, CR7 7YE
Novartis Investigative Site
Darlington, DL3 6HX
Novartis Investigative Site
Dorchester, Dorset, DT1 2JY
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Dundee, Perthshire, DD1 2BU
Novartis Investigative Site
Durham, County Durham, DH1 5TW
Novartis Investigative Site
Exeter, EX2 5AX
Novartis Investigative Site
Inverness, IV2 3UJ
Novartis Investigative Site
Kent, DA2 8DA
Novartis Investigative Site
Leicester, Leicestershire, LE2 7LX
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
London, W1G 8PH
Novartis Investigative Site
Londonderry, BT47 1SB
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Middlesbrough, TS4 3BW
Novartis Investigative Site
Milton Keynes, MK6 5LD
Novartis Investigative Site
Newport, NP20 2UB
Novartis Investigative Site
Newport, P030 5TG
Novartis Investigative Site
Norwich, NR4 7UY
Novartis Investigative Site
Oldham, Lancashire, OL1 2JH
Novartis Investigative Site
Poole, BH15 2JB
Novartis Investigative Site
Portsmouth, Hampshire, PO6 3LY
Novartis Investigative Site
Redhill, Surrey, RH1 5RH
Novartis Investigative Site
Romford, Essex, RM7 0AG
Novartis Investigative Site
Rotherham, S60 2OD
Novartis Investigative Site
Royal Bridge Wells, Kent, TN4 8AT
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF
Novartis Investigative Site
South Shields, Tyne and Wear, NE34 0PL
Novartis Investigative Site
Stevenage, SG1 4AB
Novartis Investigative Site
Sunderland, SR4 7TP
Novartis Investigative Site
Surrey, SM5 1AA
Novartis Investigative Site
Sutton Coldfield, West Midlands, B75 7RR
Novartis Investigative Site
Swansea, England, SA6 6NL
Novartis Investigative Site
Taunton, Somerset, TA1 5DA
Novartis Investigative Site
Vale of Glamorgan, CF64 2XX
Novartis Investigative Site
Worcester, WR5 1DD
Novartis Investigative Site
Yeovil, Somerset, BA21 4AT
Novartis Investigative Site
York, YO31 8HE
India45 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380 013
Novartis Investigative Site
Ahmedabad, Gujarat, 380014
Novartis Investigative Site
Ahmedabad, Gujarat, 380025
Novartis Investigative Site
Ahmedabad, 380052
Novartis Investigative Site
Anand, Gujarat, 388325
Novartis Investigative Site
Bangalore, Karnataka, 560038
Novartis Investigative Site
Bangalore, Karnataka, 560092
Novartis Investigative Site
Banglaore, Karnataka, 560054
Novartis Investigative Site
Bikaner, Rajasthan, 334003
Novartis Investigative Site
Chennai, Tamil Nadu, 600004
Novartis Investigative Site
Chennai, Tamil Nadu, 600020
Novartis Investigative Site
Delhi, National Capital Territory of Delhi, 110080
Novartis Investigative Site
Guntur, Andhra Pradesh, 522001
Novartis Investigative Site
Gurgaon, Haryana, 122001
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500012
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500082
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, 500034
Novartis Investigative Site
Hyderabad, 500 063
Novartis Investigative Site
Indore, India, 452014
Novartis Investigative Site
Jaipur, Rajasthan, 302016
Novartis Investigative Site
Kochi, Kerala, 683572
Novartis Investigative Site
Kota, Rajasthan, 324005
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226003
Novartis Investigative Site
Ludhiana, Punjab, 141002
Novartis Investigative Site
Mangalore, Karnataka, 575002
Novartis Investigative Site
Mumbai, Maharashtra, 400012
Novartis Investigative Site
Mysore, Karnataka, 570004
Novartis Investigative Site
Nagpur, Maharashtra, 400012
Novartis Investigative Site
Nagpur, Maharashtra, 440 010
Novartis Investigative Site
Nagpur, Maharashtra, 44000033
Novartis Investigative Site
Nashik, Maharashtra, 422 005
Novartis Investigative Site
Nashik, Maharashtra, 422002
Novartis Investigative Site
Nashik, Maharashtra, 422005
Novartis Investigative Site
Pune, Maharashtra, 411 005
Novartis Investigative Site
Pune, Maharashtra, 411 011
Novartis Investigative Site
Pune, Maharashtra, 411011
Novartis Investigative Site
Rajkot, Gujarat, 360001
Novartis Investigative Site
Surat, Gujarat, 395001
Novartis Investigative Site
Tirupati, Andhra Pradesh, 517501
Novartis Investigative Site
Trivandrum, Kerala, 695011
Novartis Investigative Site
Trivandrum, Kerala, 695607
Novartis Investigative Site
Vadodara, Gujarat, 390015
Novartis Investigative Site
Varanasi, Uttar Pradesh, 221 005
Novartis Investigative Site
Visakhapatnam, Andhra Pradesh, 530 013
Novartis Investigative Site
Visakhapatnam, Andhra Pradesh, 530002
Italy37 sites
Novartis Investigative Site
Albano Laziale, RM, 00041
Novartis Investigative Site
Aosta, AO, 11100
Novartis Investigative Site
Battipaglia, SA, 84091
Novartis Investigative Site
Bergamo, BG, 24128
Novartis Investigative Site
Bolzano, BZ, 39100
Novartis Investigative Site
Casorate Primo, PV, 27022
Novartis Investigative Site
Catanzaro, CZ, 88100
Novartis Investigative Site
Cava de' Tirreni, SA, 84013
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Cortona, AR, 52044
Novartis Investigative Site
Cosenza, CS, 87100
Novartis Investigative Site
Florence, FI, 50143
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Lido di Camaiore, LU, 55041
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milazzo, ME, 98057
Novartis Investigative Site
Modena, MO, 41100
Novartis Investigative Site
Monza, MB, 20900
Novartis Investigative Site
Palmanova, UD, 33057
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Perugia, PG, 06100
Novartis Investigative Site
Pescia, PT, 51017
Novartis Investigative Site
Piove di Sacco, PD, 35028
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Pozzilli, IS, 86077
Novartis Investigative Site
Roma, RM, 00163
Novartis Investigative Site
Salerno, SA, 84131
Novartis Investigative Site
San Daniele del Friuli, UD, 33038
Novartis Investigative Site
San Pietro Vernotico, BR, 72027
Novartis Investigative Site
Sassari, SS, 07100
Novartis Investigative Site
Seriate, BG, 24068
Novartis Investigative Site
Stradella, PV, 27049
Novartis Investigative Site
Thiesi, SS, 07047
Novartis Investigative Site
Tradate, VA, 21049
Novartis Investigative Site
Treviglio, BG, 24047
Novartis Investigative Site
Varese, VA, 21100
Novartis Investigative Site
Vibo Valentia, VV, 89900
Brazil32 sites
Novartis Investigative Site
Belém, Pará, 66087-660
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 20180-090
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221
Novartis Investigative Site
Brasília, Federal District, 70390-903
Novartis Investigative Site
Curitiba, Paraná, 80730-150
Novartis Investigative Site
Goiânia, Goiás, 74223-130
Novartis Investigative Site
Goiânia, Goiás, 74605-050
Novartis Investigative Site
Goiânia, Goiás, 74823-470
Novartis Investigative Site
Marília, São Paulo, 17515-000
Novartis Investigative Site
Natal, Rio Grande do Norte, 59020-035
Novartis Investigative Site
Passo Fundo, Rio Grande do Sul, 99010-080
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90620-001
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90880-480
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 92425900
Novartis Investigative Site
Recife, Pernambuco, 50100-030
Novartis Investigative Site
Recife, Pernambuco, 50100-130
Novartis Investigative Site
Recife, Pernambuco, 52051 - 38
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14055-370
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-590
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 22261-010
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 22280-020
Novartis Investigative Site
Salvador, Estado de Bahia, 40140-110
Novartis Investigative Site
Salvador, Estado de Bahia, 41810-010
Novartis Investigative Site
Santo André, São Paulo, 09030-640
Novartis Investigative Site
Santo André, São Paulo, 09190-615
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15015-750
Novartis Investigative Site
São Luís, Maranhão, 65020-070
Novartis Investigative Site
São Paulo, São Paulo, 01327-010
Novartis Investigative Site
São Paulo, São Paulo, 01506-000
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Novartis Investigative Site
Uberlândia, Minas Gerais, 38400-368
Novartis Investigative Site
Votuporanga, São Paulo, 15500-003
Hungary30 sites
Novartis Investigative Site
Baja, 6500
Novartis Investigative Site
Balatonfüred, H-8231
Novartis Investigative Site
Budapest, Hungary, 1122
Novartis Investigative Site
Budapest, Hungary, 1134
Novartis Investigative Site
Budapest, 1021
Novartis Investigative Site
Budapest, 1027
Novartis Investigative Site
Budapest, 1043
Novartis Investigative Site
Budapest, 1085
Novartis Investigative Site
Budapest, 1096
Novartis Investigative Site
Budapest, 1125
Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Budapest, 1145
Novartis Investigative Site
Budapest, H-1032
Novartis Investigative Site
Budapest, H-1096
Novartis Investigative Site
Budapest, H-1106
Novartis Investigative Site
Cegléd, Hungary, 2700
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Eger, H-3300
Novartis Investigative Site
Hódmezővásárhely, 6800
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Miskolc, Hungary, 3526
Novartis Investigative Site
Nagykanizsa, 8800
Novartis Investigative Site
Nyiregyháza, 4400
Novartis Investigative Site
Pécs, Baranya, 7621
Novartis Investigative Site
Pécs, 7643
Novartis Investigative Site
Sopron, 9400
Novartis Investigative Site
Szeged, H-6720
Novartis Investigative Site
Székesfehérvár, 8000
Novartis Investigative Site
Szekszárd, 7100
Novartis Investigative Site
Zalaegerszeg, 8900
South Africa30 sites
Novartis Investigative Site
Alberton, 1449
Novartis Investigative Site
Bloemfontein, Free State, 9301
Novartis Investigative Site
Bloemfontein, 9301
Novartis Investigative Site
Bloemfontein, 9317
Novartis Investigative Site
Breyten, 2330
Novartis Investigative Site
Brits, 250
Novartis Investigative Site
Cape Town, 7405
Novartis Investigative Site
Cape Town, 7500
Novartis Investigative Site
Cape Town, 7505
Novartis Investigative Site
Cape Town, 7531
Novartis Investigative Site
Cape Town
Novartis Investigative Site
Durban, 4001
Novartis Investigative Site
Durban, 4052
Novartis Investigative Site
Durban, 4110
Novartis Investigative Site
East London
Novartis Investigative Site
eMkhomazi, 4170
Novartis Investigative Site
Gatesville, 7764
Novartis Investigative Site
Johannesburg, 2193
Novartis Investigative Site
Kempton Park, 1620
Novartis Investigative Site
Middelburg, Mpumalanga, 1050
Novartis Investigative Site
Mthatha, Eastern Cape
Novartis Investigative Site
Paarl, Western Cape, 7626
Novartis Investigative Site
Port Elizabeth, 6014
Novartis Investigative Site
Pretoria, 0121
Novartis Investigative Site
Pretoria, 0184
Novartis Investigative Site
Pretoria
Novartis Investigative Site
Somerset West, Western Cape, 7130
Novartis Investigative Site
Soweto, Gauteng, 2013
Novartis Investigative Site
Witbank
Novartis Investigative Site
Worcester, 6850
Canada28 sites
Novartis Investigative Site
Cambridge, Ontario, N1R 6V6
Novartis Investigative Site
Granby, Quebec, J2G 1T7
Novartis Investigative Site
Greater Sudbury, Ontario, P3E 3B8
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9
Novartis Investigative Site
Kitchener, Ontario, N2M 5N4
Novartis Investigative Site
Lachine, Quebec, H8S 2E4
Novartis Investigative Site
Laval, Quebec, H7M 3L9
Novartis Investigative Site
Lévis, Quebec, G6V 4Z5
Novartis Investigative Site
London, Ontario, N6A 5A5
Novartis Investigative Site
Longueuil, Quebec, J4M 2X1
Novartis Investigative Site
Moncton, New Brunswick, E1G 1A7
Novartis Investigative Site
Montreal, Quebec, H2W 1T8
Novartis Investigative Site
Montreal, Quebec, H3A 1A1
Novartis Investigative Site
Montreal, Quebec, H3G 1A4
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
New Westminster, British Columbia, V3L 3W4
Novartis Investigative Site
Oshawa, Ontario, L1J 2K1
Novartis Investigative Site
Regina, Saskatchewan, S4P 0w5
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5
Novartis Investigative Site
Sherbrooke, Quebec, J1G-2E8
Novartis Investigative Site
St-Georges Beauce, Quebec, G5Y 4T8
Novartis Investigative Site
Surrey, British Columbia, V3V 1N1
Novartis Investigative Site
Thetford-Mines, Quebec, G6G 2V4
Novartis Investigative Site
Toronto, Ontario, M5B 1W8
Novartis Investigative Site
Toronto, Ontario, M5G 1X5
Novartis Investigative Site
Toronto, Ontario, M5G 2N2
Novartis Investigative Site
Victoria, British Columbia, V8R4R2
Novartis Investigative Site
Weston, Ontario, M9N 1W4
France28 sites
Novartis Investigative Site
Abbeville, 80100
Novartis Investigative Site
Bayonne, 64100
Novartis Investigative Site
Bayonne, 64109
Novartis Investigative Site
Béziers, 34525
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Caen, 14000
Novartis Investigative Site
Cholet, 49325
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Essey-lès-Nancy, 54270
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Lagny-sur-Marne, 77405
Novartis Investigative Site
Langres, 52206
Novartis Investigative Site
Le Chesnay
Novartis Investigative Site
Le Plessis-Robinson, 92350
Novartis Investigative Site
Limoges, 87001
Novartis Investigative Site
Lomme, 59462
Novartis Investigative Site
Montpellier, 34195
Novartis Investigative Site
Nice, 06602
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Saint-Aubin-lès-Elbeuf, 76410
Novartis Investigative Site
Strasbourg, Cedex, 67091
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Tourcoing, 59208
Novartis Investigative Site
Valencienne, 59322
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Czechia25 sites
Novartis Investigative Site
Beroun, Czech Republic, 266 01
Novartis Investigative Site
Bílovec, CZE, 743 01
Novartis Investigative Site
Brandýs nad Labem, Czech Republic, 250 01
Novartis Investigative Site
Hořovice, Czech Republic, 268 01
Novartis Investigative Site
Jablonec nad Nisou, Czech Republic, 466 01
Novartis Investigative Site
Karlovy Vary, Czech Republic, 360 09
Novartis Investigative Site
Kladno, Czech Republic, 272 80
Novartis Investigative Site
Klatovy, Czech Republic, 339 01
Novartis Investigative Site
Kolín, 280 20
Novartis Investigative Site
Liberec V Kristianova, Czech Republic, 460 05
Novartis Investigative Site
Mělník, Czech Republic, 276 01
Novartis Investigative Site
Olomouc, Czech Republic, 779 00
Novartis Investigative Site
Pilsen, Czech Republic, 301 00
Novartis Investigative Site
Prague, Czech Republic, 142 00
Novartis Investigative Site
Prague, CZE, 128 08
Novartis Investigative Site
Prague, 110 00
Novartis Investigative Site
Prague, 128 08
Novartis Investigative Site
Prague, 150 30
Novartis Investigative Site
Prague 10, Vrsovice, Czech Republic, 10100
Novartis Investigative Site
Semily, Czech Republic, 513 31
Novartis Investigative Site
Strakonice, Czech Republic, 38601
Novartis Investigative Site
Třebíč, Czech Republic, 674 01
Novartis Investigative Site
Uherské Hradiště, 686 01
Novartis Investigative Site
Uherské Hradiště, 68601
Novartis Investigative Site
Ústí nad Labem, Czech Republic, 400 01
Slovakia24 sites
Novartis Investigative Site
Bratislava, Slovak Republic, 841 04
Novartis Investigative Site
Bratislava, Slovakia, 821 07
Novartis Investigative Site
Bratislava, Slovakia, 841 04
Novartis Investigative Site
Bratislava, 81369
Novartis Investigative Site
Bratislava, 851 07
Novartis Investigative Site
Brezno, Slovak Republic, 977 42
Novartis Investigative Site
Dolný Kubín, 026 01
Novartis Investigative Site
Dunajská Streda, Slovakia, 929 01
Novartis Investigative Site
Košice, Slovak Republic, 040 22
Novartis Investigative Site
Košice, Slovakia, 040 01
Novartis Investigative Site
Košice, Slovakia, 04001
Novartis Investigative Site
Kráľovský Chlmec, Slovakia, 077 01
Novartis Investigative Site
Levice, Slovak Republic, 93401
Novartis Investigative Site
Levice, Slovakia, 934 01
Novartis Investigative Site
Levice, Slovakia, 934 05
Novartis Investigative Site
Lučenec, Slovakia, 984 01
Novartis Investigative Site
Martin, Slovakia, 036 01
Novartis Investigative Site
Nitra, Slovakia, 949 88
Novartis Investigative Site
Prešov, Slovak Republic, 080 01
Novartis Investigative Site
Prešov, Slovak Republic, 08001
Novartis Investigative Site
Svidník, Slovak Republic, 08901
Novartis Investigative Site
Trnava, Slovakia, 917 01
Novartis Investigative Site
Trnava, Slovakia, 91701
Novartis Investigative Site
Vranov nad Topľou, Slovak Republic, 09301
Bulgaria22 sites
Novartis Investigative Site
Burgas, Bulgaria, 8000
Novartis Investigative Site
Haskovo, 6300
Novartis Investigative Site
Pazardzhik, 4400
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Plovdiv, Bulgaria, 4000
Novartis Investigative Site
Plovdiv, Bulgaria, 4004
Novartis Investigative Site
Plovdiv, 4002
Novartis Investigative Site
Rousse, 7002
Novartis Investigative Site
Shumen, 9700
Novartis Investigative Site
Silistra, 7500
Novartis Investigative Site
Sofia, Bulgaria, 1309
Novartis Investigative Site
Sofia, Bulgaria, 1431
Novartis Investigative Site
Sofia, Bulgaria, 1505
Novartis Investigative Site
Sofia, Bulgaria, 1527
Novartis Investigative Site
Sofia, Bulgaria, 1606
Novartis Investigative Site
Sofia, 1202
Novartis Investigative Site
Sofia, 1233
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Sofia, 1606
Novartis Investigative Site
Stara Zagora, 6000
Novartis Investigative Site
Varna, 9010
Novartis Investigative Site
Veliko Tarnovo, 5000
Netherlands22 sites
Novartis Investigative Site
's-Hertogenbosch, 5223 GZ
Novartis Investigative Site
Amersfoort, 3813 TZ
Novartis Investigative Site
Arnhem, 6815 AD
Novartis Investigative Site
Blaricum, 1261 AN
Novartis Investigative Site
Breda, 4818 CK
Novartis Investigative Site
Delft, 2625 AD
Novartis Investigative Site
Ede, Netherlands, 6716 RP
Novartis Investigative Site
Eindhoven, Netherlands, 5623 EJ
Novartis Investigative Site
Goes, 4462 RA
Novartis Investigative Site
Gorinchem, 4204 AA
Novartis Investigative Site
Hardenberg, Netherlands, 7770 AA
Novartis Investigative Site
Harderwijk, Netherlands, 3840 AC
Novartis Investigative Site
Heerenveen, 8441 PW
Novartis Investigative Site
Hengelo, 7555 DL
Novartis Investigative Site
Hoorn, 1625 HV
Novartis Investigative Site
Maastricht, 6229 HX
Novartis Investigative Site
Nijmegen, 6525 GA
Novartis Investigative Site
Oss, NL, 5342 BT
Novartis Investigative Site
Sneek, 8601 ZK
Novartis Investigative Site
The Hague, 2512 VA
Novartis Investigative Site
Tilburg, 5022 GC
Novartis Investigative Site
Veldhoven, 5504 DB
Romania22 sites
Novartis Investigative Site
Arad, Romania, 310158
Novartis Investigative Site
Bucharest, District 1, 014461
Novartis Investigative Site
Bucharest, District 1
Novartis Investigative Site
Bucharest, District 2, 021345
Novartis Investigative Site
Bucharest, District 5, 050538
Novartis Investigative Site
Bucharest, Romania, 020054
Novartis Investigative Site
Bucharest, Romania, 050659
Novartis Investigative Site
Bucharest, 011728
Novartis Investigative Site
Bucharest, 050098
Novartis Investigative Site
Bucharest, 060011
Novartis Investigative Site
Bucharest, 062272
Novartis Investigative Site
Craiova, Jud. Dolj, 200147
Novartis Investigative Site
Craiova, Jud.Dolj, 200235
Novartis Investigative Site
Deva, Romania, 330084
Novartis Investigative Site
Piteşti, 110114
Novartis Investigative Site
Ploieşti, Jud.Prahova, 100410
Novartis Investigative Site
Timișoara, Jud. Timis, 300359
Novartis Investigative Site
Timișoara, Romania, 300020
Novartis Investigative Site
Timișoara, Romania, 300041
Novartis Investigative Site
Timișoara, Romania, 300361
Novartis Investigative Site
Timișoara, Romania, 300736
Novartis Investigative Site
Timișoara, 300310
Spain22 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Alcalá de Henares, Madrid, 28805
Novartis Investigative Site
Alicante, Valencia, 03004
Novartis Investigative Site
Almería, Andalusia, 04120
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
El Palmar, Murcia, 30120
Novartis Investigative Site
Ferrol, Galicia, 15405
Novartis Investigative Site
Madrid, Madrid, 28007
Novartis Investigative Site
Majadahonda, Madrid, 28222
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Mallorca, Balearic Islands, 07198
Novartis Investigative Site
Marbella, Andalusia, 29600
Novartis Investigative Site
Mérida, Extremadura, 06800
Novartis Investigative Site
Móstoles, Madrid, 28935
Novartis Investigative Site
Sant Joan Despí, Catalonia, 08970
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Seville, Andalusia, 41017
Novartis Investigative Site
Valencia, Valencia, 46010
Novartis Investigative Site
Valencia, Valencia, 46015
Novartis Investigative Site
Vigo, Galicia, 36211
Poland21 sites
Novartis Investigative Site
Bialystok, 15-875
Novartis Investigative Site
Gdynia, 81-157
Novartis Investigative Site
Gdynia, 81-472
Novartis Investigative Site
Gdynia, 81-519
Novartis Investigative Site
Gdynia, 81-548
Novartis Investigative Site
Gliwice, 44-100
Novartis Investigative Site
Golub-Dobrzyń, 87-400
Novartis Investigative Site
Katowice, 40-084
Novartis Investigative Site
Katowice, 40-530
Novartis Investigative Site
Katowice, 40-645
Novartis Investigative Site
Krakow, 30-015
Novartis Investigative Site
Krakow, 30-082
Novartis Investigative Site
Kutno, 99-300
Novartis Investigative Site
Lodz, 91-302
Novartis Investigative Site
Lublin, 20-857
Novartis Investigative Site
Oława, 55-200
Novartis Investigative Site
Skierniewice, 96-100
Novartis Investigative Site
Wroclaw, 50-088
Novartis Investigative Site
Wroclaw, 51-312
Novartis Investigative Site
Wroclaw, 52-612
Novartis Investigative Site
Zabrze, 41-800
China16 sites
Novartis Investigative Site
Baotou, 014040
Novartis Investigative Site
Beijing, Beijing Municipality, 100037
Novartis Investigative Site
Beijing, 100029
Novartis Investigative Site
Beijing, 100044
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chongqing, 400037
Novartis Investigative Site
Hangzhou, Zhejiang, 310009
Novartis Investigative Site
Harbin, Heilongjiang, 150001
Novartis Investigative Site
Nanjing, Jiangsu, 210009
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Nanjing, Jiangsu
Novartis Investigative Site
Shanghai, 200080
Novartis Investigative Site
Shenyang, Liaoning, 110003
Novartis Investigative Site
Xi’an, Shanxi, 710061
Belgium14 sites
Novartis Investigative Site
Antwerp, 2060
Novartis Investigative Site
Baudour, 7331
Novartis Investigative Site
Bonheiden, 2820
Novartis Investigative Site
Brasschaat, 2930
Novartis Investigative Site
Bruges, 8000
Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Brussels, 1090
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Hasselt, 3500
Novartis Investigative Site
Heusden-Zolder, Belgium, 3550
Novartis Investigative Site
La Louvière, 7100
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Ottignies, 1340
Novartis Investigative Site
Ronse, 9600
Turkey (Türkiye)14 sites
Novartis Investigative Site
Adana, 01250
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Antalya, 07070
Novartis Investigative Site
Balcova / Izmir, 35340
Novartis Investigative Site
Edirne, 22030
Novartis Investigative Site
Etlik / Ankara, 06018
Novartis Investigative Site
Haseki / Istanbul, 34096
Novartis Investigative Site
Istanbul, Turkey, 34304
Novartis Investigative Site
Istanbul, 34093
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Mersin, 33079
Novartis Investigative Site
Meselik / Eskisehir, 26480
Novartis Investigative Site
Sivas, 58140
South Korea13 sites
Novartis Investigative Site
Busan, Busan, 602-739
Novartis Investigative Site
Daegu, 705-703
Novartis Investigative Site
Daegu, 705-718
Novartis Investigative Site
Gwangju, Gwangju, 501-757
Novartis Investigative Site
Pusan, 614-735
Novartis Investigative Site
Seoul, Korea, 120-752
Novartis Investigative Site
Seoul, Korea, 137-701
Novartis Investigative Site
Seoul, Korea, 138-736
Novartis Investigative Site
Seoul, 110-102
Novartis Investigative Site
Seoul, 134-701
Novartis Investigative Site
Seoul, 156-707
Novartis Investigative Site
Suwon, Gyeonggi-do, 443-380
Novartis Investigative Site
Wŏnju, Gangwon-do, 220-701
Colombia12 sites
Novartis Investigative Site
Barranquilla, Atlántico
Novartis Investigative Site
Barranquilla, Colombia
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogota, Cundinamarca, 0000
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Bucaramanga, Santander Department
Novartis Investigative Site
Cali, Colombia
Novartis Investigative Site
Cartagena, Departamento de Bolívar
Novartis Investigative Site
Cartegena, Colombia
Novartis Investigative Site
Florida Blanca
Novartis Investigative Site
Floridablanca, Santander Department, 57-7
Novartis Investigative Site
Medellín
Mexico12 sites
Novartis Investigative Site
Aguascalientes, Aguascalientes, 20230
Novartis Investigative Site
Guadalajara, Jalisco, 44280
Novartis Investigative Site
Mexico City, Mexico City, 03100
Novartis Investigative Site
Mexico City, Mexico City, 06700
Novartis Investigative Site
Mexico City, Mexico City, 06720
Novartis Investigative Site
Mexico City, Mexico City, 07300
Novartis Investigative Site
Monterrey, Nuevo León, 64710
Novartis Investigative Site
Querétaro City, Querétaro, 76000
Novartis Investigative Site
San Juan del Río, Querétaro, 76800
Novartis Investigative Site
San Luis Potosí City, San Luis Potosí, 78200
Novartis Investigative Site
San Luis Potosí City, San Luis Potosí, 78240
Novartis Investigative Site
Zapopan, Jalisco, 45200
Philippines11 sites
Novartis Investigative Site
Bulacan, Philippines, 3020
Novartis Investigative Site
Lipa City, Batangas, 4217
Novartis Investigative Site
Manila, Philippines, 1000
Novartis Investigative Site
Manila, Philippines, 1003
Novartis Investigative Site
Manila
Novartis Investigative Site
Pasig, 1605
Novartis Investigative Site
Quezon City, Manila, 1100
Novartis Investigative Site
Quezon City, National Capital Region, 1109
Novartis Investigative Site
Quezon City, 1100
Novartis Investigative Site
Quezon City, 1102
Novartis Investigative Site
San Juan City, Philippines, 1500
Denmark10 sites
Novartis Investigative Site
Aarhus C, DK-8000
Novartis Investigative Site
Copenhagen, DK-2100
Novartis Investigative Site
Esbjerg, DK-6700
Novartis Investigative Site
Hellerup, Denmark, DK-2900
Novartis Investigative Site
Herning, DK-7400
Novartis Investigative Site
Randers NØ, DK-8930
Novartis Investigative Site
Roskilde, DK-4000
Novartis Investigative Site
Svendborg, DK-5700
Novartis Investigative Site
Vejle, DK-7100
Novartis Investigative Site
Viborg, DK-8800
Portugal10 sites
Novartis Investigative Site
Amadora, Portugal, 2720-276
Novartis Investigative Site
Covilha, Portugal, 6200-251
Novartis Investigative Site
Guimarães, Portugal, 4835-044
Novartis Investigative Site
Lisbon, Portugal, 1169-024
Novartis Investigative Site
Lisbon, Portugal, 1449-005
Novartis Investigative Site
Penafiel, Portugal, 4564-007
Novartis Investigative Site
Portalegre, Portugal, 7300-853
Novartis Investigative Site
Porto, Porto District, 4200-319
Novartis Investigative Site
Setúbal, 2910-446
Novartis Investigative Site
Vila Real, Portuigal, 5000-508
Israel9 sites
Novartis Investigative Site
Ashkelon, 78278
Novartis Investigative Site
Hadera, 38100
Novartis Investigative Site
Haifa, 31096
Novartis Investigative Site
Haifa, 3436212
Novartis Investigative Site
Jerusalem, 91031
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Rehovot, 76100
Novartis Investigative Site
Safed, Israel, 13100
Sweden9 sites
Novartis Investigative Site
Gothenburg, 416 85
Novartis Investigative Site
Gothenburg
Novartis Investigative Site
Härnösand, 871 82
Novartis Investigative Site
Helsingborg, 25232
Novartis Investigative Site
Karlshamn, 37480
Novartis Investigative Site
Lund, 221 85
Novartis Investigative Site
Motala, 59185
Novartis Investigative Site
Stockholm, 141 86
Novartis Investigative Site
Vällingby, 162 68
Chile8 sites
Novartis Investigative Site
Los Ángeles, Biobio, 4440000
Novartis Investigative Site
San Miguel, Santiago Metropolitan, 8900000
Novartis Investigative Site
Santiago, Santiago Metropolitan, 8360160
Novartis Investigative Site
Santiago, Santiago Metropolitan
Novartis Investigative Site
Talcahuano
Novartis Investigative Site
Temuco, Araucania, 4780000
Novartis Investigative Site
Temuco, Cautin
Novartis Investigative Site
Vitacura, Santiago Metropolitan, 7630000
Peru8 sites
Novartis Investigative Site
Arequipa, Arequipa, Areq01
Novartis Investigative Site
Bellavista, Lima region, Callao 02
Novartis Investigative Site
Jesus Maria, Lima region, 11
Novartis Investigative Site
La Molina, Lima region, 12
Novartis Investigative Site
Lima Cercado, Lima region, 01
Novartis Investigative Site
San Borja, Lima region, 41
Novartis Investigative Site
San Isidro, Lima region, 27
Novartis Investigative Site
San Miguel, Lima region, 32
Taiwan8 sites
Novartis Investigative Site
Changhua, 500
Novartis Investigative Site
Kaohsiung City, 82445
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Tainan, Taiwan ROC
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, 114
Novartis Investigative Site
Taipei, Taiwan, ROC, 112
Novartis Investigative Site
Yilan
Latvia6 sites
Novartis Investigative Site
Daugavplis, LV-5417
Novartis Investigative Site
Kuldīga, LV-3300
Novartis Investigative Site
Liepāja, LV, LV-3414
Novartis Investigative Site
Preiļi, LV-5301
Novartis Investigative Site
Riga, 1002
Novartis Investigative Site
Ventspils, LV-3601
Finland5 sites
Novartis Investigative Site
HUS, 00029
Novartis Investigative Site
Kemi, FIN-94100
Novartis Investigative Site
Kuopio, Finland, 70100
Novartis Investigative Site
Oulu, 90100
Novartis Investigative Site
Tampere, 33521
Lithuania5 sites
Novartis Investigative Site
Kaunas, 50009
Novartis Investigative Site
Kaunas, LT-49387
Novartis Investigative Site
Kėdainiai, LT-57164
Novartis Investigative Site
Šiauliai, LT-76231
Novartis Investigative Site
Vilnius, LT-08661
Thailand5 sites
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Khon Kaen, 40002
Novartis Investigative Site
Muang, Muang, 65000
Novartis Investigative Site
Muang, Thailand, 12120
Novartis Investigative Site
Taladkwan, Changwat Nonthaburi, 11000
Venezuela5 sites
Novartis Investigative Site
Caracas, Distrito Federal, 1060
Novartis Investigative Site
Caracas, Miranda, 1061
Novartis Investigative Site
Maracaibo, Zulia, 4011
Novartis Investigative Site
Maracaibo, Zulia
Novartis Investigative Site
Maturín, Monagas, 6201
Ecuador4 sites
Novartis Investigative Site
Guayaquil, Guayas, 412
Novartis Investigative Site
Guayaquil, Guayas, 559
Novartis Investigative Site
Guayaquil, Guayas
Novartis Investigative Site
Quito, Pichincha, 1701
Estonia4 sites
Novartis Investigative Site
Haabneeme, Viimsi Vald, 74001
Novartis Investigative Site
Tallinn, Estonia, 10138
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, 50410
Hong Kong4 sites
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Hong Kong
Novartis Investigative Site
Hong Kong SAR
Malaysia4 sites
Novartis Investigative Site
Kuala Lumpur, 50400
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Kuching, Sarawak, 94300
Novartis Investigative Site
Pulau Pinang, Pulau Pinang, 10990
Singapore4 sites
Novartis Investigative Site
Singapore, Singapore, 119074
Novartis Investigative Site
Singapore, Singapore, 169609
Novartis Investigative Site
Singapore, Singapore, 308433
Novartis Investigative Site
Singapore, Singapore, 768825
Guatemala3 sites
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01011
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01015
Iceland3 sites
Novartis Investigative Site
Kopavogur, 201
Novartis Investigative Site
Reykjavik, IS-101
Novartis Investigative Site
Reykjavik, IS-109
Dominican Republic2 sites
Novartis Investigative Site
Santo Domingo, Republica Dominicana
Novartis Investigative Site
Santo Domingo, Santo Domingo Province
Panama2 sites
Novartis Investigative Site
Panama City, Provincia de Panamá, 0831-02351
Novartis Investigative Site
Panama City, Provincia de Panamá
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction
The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).
- Being tested
- LCZ696 200 mg BID, Enalapril 10 mg BID
- Keywords
- chronic heart failure, cardiovascular death, hospitalization, outcome study, BNP, KCCQ, eGFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ696 200 mg BIDDrug
LCZ696 200 mg BID
Enalapril 10 mg BIDDrug
Enalapril 10 mg BID
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 | Experimental | single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period Receives: Drug: LCZ696 200 mg BID |
| Enalapril | Active comparator | single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period Receives: Drug: Enalapril 10 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
Measured: up to 51 months
Secondary outcomes (5)
Number of Patients - All-cause Mortality
Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014
Measured: up to 51 months
Number of Patients Reported With Adjudicated Primary Causes of Death
Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014
Measured: up to 51 months
Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: Baseline, Month 8
Number of Patients With First Confirmed Renal Dysfunction
Number of patients with first confirmed renal dysfunction
Measured: up to 51 months
Percentage of Participants With New Onset of Atrial Fibrillation (AF)
Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).
Measured: up to 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Early termination was approved due to compelling efficacy of LCZ696 in patients with HF \& reduced EF after final pre-specified interim analysis 28-Mar-2014.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035255
- Sponsor's protocol ID
- CLCZ696B2314
- Other IDs
- 2009-015834-31, 2009
- Acronym
- PARADIGM-HF
- Status last verified
- Jul 2016
- First submitted
- 16 Dec 2009
- Last updated
- 15 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Yang M, Henderson AD, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Rouleau JL, Swedberg K, Vaduganathan M, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Rizkala A, Lewis EF, Jhund PS, Solomon SD, McMurray JJV. Sacubitril/valsartan and quality of life assessed using the EuroQol Five-dimension Three-level questionnaire level sum score (EQ-5D-3L-LSS) in patients with HFrEF and HFmrEF/HFpEF. Eur Heart J Cardiovasc Pharmacother. 2025 Nov 4;11(7):574-589. doi: 10.1093/ehjcvp/pvaf064.
PubMed 40839760Chimura M, Butt JH, Matsumoto S, McMurray EGM, Henderson AD, Talebi A, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Packer M, Jhund PS, McMurray JJV. Comprehensive Analysis of the Effects of Sacubitril/Valsartan According to Sex Among Patients With Heart Failure and Reduced Ejection Fraction in PARADIGM-HF. J Am Heart Assoc. 2025 May 6;14(9):e038249. doi: 10.1161/JAHA.124.038249. Epub 2025 Apr 23.
PubMed 40265590Gupta SD, Butt JH, McMurray EGM, Talebi A, Matsumoto S, Rizkala AR, Henderson AD, Desai AS, Lefkowitz M, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, McMurray JJV; PARADIGM-HF Investigators and Committees. Effects of sacubitril/valsartan according to background beta-blocker therapy in patients with heart failure and reduced ejection fraction: Insights from PARADIGM-HF. Eur J Heart Fail. 2025 May;27(5):779-787. doi: 10.1002/ejhf.3515. Epub 2024 Nov 19.
PubMed 39563094Lu H, Claggett BL, Packer M, Pfeffer MA, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund PS, McMurray JJV, Solomon SD, Vaduganathan M. Visit-to-visit changes in heart rate in heart failure: A pooled participant-level analysis of the PARADIGM-HF and PARAGON-HF trials. Eur J Heart Fail. 2025 Jan;27(1):60-68. doi: 10.1002/ejhf.3487. Epub 2024 Oct 22.
PubMed 39439294Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.
PubMed 39210725Patel-Murray NL, Zhang L, Claggett BL, Xu D, Serrano-Fernandez P, Healey M, Wandel S, Chen CW, Jacob J, Xu H, Turner GM, Chutkow W, Yates DP, O'Donnell CJ, Prescott MF, Lefkowitz M, Gimpelewicz CR, Beste MT, Zhao F, Gou L, Desai AS, Jhund PS, Packer M, Pfeffer MA, Redfield MM, Rouleau JL, Zannad F, Zile MR, McMurray JJV, Mendelson MM, Solomon SD, Cunningham JW. Aptamer Proteomics for Biomarker Discovery in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Proteomic Substudy. J Am Heart Assoc. 2024 Jul 2;13(13):e033544. doi: 10.1161/JAHA.123.033544. Epub 2024 Jun 21.
PubMed 38904251Chatur S, Neuen BL, Claggett BL, Beldhuis IE, Mc Causland FR, Desai AS, Rouleau JL, Zile MR, Lefkowitz MP, Packer M, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan Across the Spectrum of Renal Impairment in Patients With Heart Failure. J Am Coll Cardiol. 2024 Jun 4;83(22):2148-2159. doi: 10.1016/j.jacc.2024.03.392. Epub 2024 Apr 6.
PubMed 38588927Bhatt AS, Vaduganathan M, Claggett BL, Kulac IJ, Anand IS, Desai AS, Fang JC, Hernandez AF, Jhund PS, Kosiborod MN, Sabatine MS, Shah SJ, Vardeny O, McMurray JJV, Solomon SD, Gaziano TA. Cost Effectiveness of Dapagliflozin for Heart Failure Across the Spectrum of Ejection Fraction: An Economic Evaluation Based on Pooled, Individual Participant Data From the DELIVER and DAPA-HF Trials. J Am Heart Assoc. 2024 Mar 5;13(5):e032279. doi: 10.1161/JAHA.123.032279. Epub 2024 Feb 23.
PubMed 38390793Curtain JP, Adamson C, Docherty KF, Jhund PS, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJV. Prevalent and Incident Anemia in PARADIGM-HF and the Effect of Sacubitril/Valsartan. JACC Heart Fail. 2023 Jul;11(7):749-759. doi: 10.1016/j.jchf.2022.12.012. Epub 2023 Apr 12.
PubMed 37407154Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.
PubMed 37366061Tolomeo P, Butt JH, Kondo T, Campo G, Desai AS, Jhund PS, Kober L, Lefkowitz MP, Rouleau JL, Solomon SD, Swedberg K, Vaduganathan M, Zile MR, Packer M, McMurray JJV. Importance of cystatin C in estimating glomerular filtration rate: the PARADIGM-HF trial. Eur Heart J. 2023 Jun 25;44(24):2202-2212. doi: 10.1093/eurheartj/ehad210.
PubMed 37051752Butt JH, Ibrahim W, Dewan P, Desai AS, Kober L, Prescott MF, Lefkowitz MP, Rouleau JL, Solomon SD, Zile MR, Packer M, Jhund PS, McMurray JJV. Urinary cGMP (Cyclic Guanosine Monophosphate)/BNP (B-Type Natriuretic Peptide) Ratio, Sacubitril/Valsartan, and Outcomes in Heart Failure With Reduced Ejection Fraction: An Analysis of the PARADIGM-HF Trial. Circ Heart Fail. 2023 Mar;16(3):e010111. doi: 10.1161/CIRCHEARTFAILURE.122.010111. Epub 2023 Jan 25.
PubMed 36943907Rohde LE, Zimerman A, Vaduganathan M, Claggett BL, Packer M, Desai AS, Zile M, Rouleau J, Swedberg K, Lefkowitz M, Shi V, McMurray JJV, Solomon SD. Associations Between New York Heart Association Classification, Objective Measures, and Long-term Prognosis in Mild Heart Failure: A Secondary Analysis of the PARADIGM-HF Trial. JAMA Cardiol. 2023 Feb 1;8(2):150-158. doi: 10.1001/jamacardio.2022.4427.
PubMed 36477809Vaduganathan M, Claggett BL, McMurray JJV, Solomon SD. Health Status Trajectories Before and After Hospitalization for Heart Failure. Circulation. 2022 Jun 21;145(25):1872-1874. doi: 10.1161/CIRCULATIONAHA.122.059282. Epub 2022 May 21. No abstract available.
PubMed 35603665Toenges G, Mutze T, Jahn-Eimermacher A. A comparison of semiparametric approaches to evaluate composite endpoints in heart failure trials. Stat Med. 2021 Nov 20;40(26):5702-5724. doi: 10.1002/sim.9149. Epub 2021 Jul 30.
PubMed 34327735
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT01035255
- Acronym / sponsor ID
- PARADIGM-HF / CLCZ696B2314
- Keywords
- chronic heart failure, cardiovascular death, hospitalization, outcome study, BNP, KCCQ, eGFR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination was approved due to compelling efficacy of LCZ696 in patients with HF \& reduced EF after final pre-specified interim analysis 28-Mar-2014.
- Enrolment
- 8,442 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Dec 2009 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCZ696 | Experimental | Drug: LCZ696 200 mg BIDsingle-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period |
| Enalapril | Active comparator | Drug: Enalapril 10 mg BIDsingle-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must give written informed consent before any assessment is performed.
- Outpatients ≥ 18 years of age, male or female.
- Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =< 35%) and elevated BNP.
- Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
- Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.
Key exclusion criteria (10 listed)
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
- Previous history of intolerance to recommended target doses of ACEIs or ARBs
- Known history of angioedema.
- Requirement of treatment with both ACEIs and ARBs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCZ696 200 mg BIDLCZ696 200 mg BID | Drug | LCZ696 |
| Enalapril 10 mg BIDEnalapril 10 mg BID | Drug | Enalapril |
Primary outcome
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Time frame: up to 51 months
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
5 secondary outcomes
Number of Patients - All-cause Mortality
Time frame: up to 51 months
Number of Patients Reported With Adjudicated Primary Causes of Death
Time frame: up to 51 months
Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Time frame: Baseline, Month 8
Number of Patients With First Confirmed Renal Dysfunction
Time frame: up to 51 months
Percentage of Participants With New Onset of Atrial Fibrillation (AF)
Time frame: up to 51 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40839760Yang M, Henderson AD, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Rouleau JL, Swedberg K, Vaduganathan M, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Rizkala A, Lewis EF, Jhund PS, Solomon SD, McMurray JJV. Sacubitril/valsartan and quality of life assessed using the EuroQol Five-dimension Three-level questionnaire level sum score (EQ-5D-3L-LSS) in patients with HFrEF and HFmrEF/HFpEF. Eur Heart J Cardiovasc Pharmacother. 2025 Nov 4;11(7):574-589. doi: 10.1093/ehjcvp/pvaf064.
- Derived from this study: PubMed 40265590Chimura M, Butt JH, Matsumoto S, McMurray EGM, Henderson AD, Talebi A, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Packer M, Jhund PS, McMurray JJV. Comprehensive Analysis of the Effects of Sacubitril/Valsartan According to Sex Among Patients With Heart Failure and Reduced Ejection Fraction in PARADIGM-HF. J Am Heart Assoc. 2025 May 6;14(9):e038249. doi: 10.1161/JAHA.124.038249. Epub 2025 Apr 23.
- Derived from this study: PubMed 39563094Gupta SD, Butt JH, McMurray EGM, Talebi A, Matsumoto S, Rizkala AR, Henderson AD, Desai AS, Lefkowitz M, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, McMurray JJV; PARADIGM-HF Investigators and Committees. Effects of sacubitril/valsartan according to background beta-blocker therapy in patients with heart failure and reduced ejection fraction: Insights from PARADIGM-HF. Eur J Heart Fail. 2025 May;27(5):779-787. doi: 10.1002/ejhf.3515. Epub 2024 Nov 19.
- Derived from this study: PubMed 39439294Lu H, Claggett BL, Packer M, Pfeffer MA, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund PS, McMurray JJV, Solomon SD, Vaduganathan M. Visit-to-visit changes in heart rate in heart failure: A pooled participant-level analysis of the PARADIGM-HF and PARAGON-HF trials. Eur J Heart Fail. 2025 Jan;27(1):60-68. doi: 10.1002/ejhf.3487. Epub 2024 Oct 22.
- Derived from this study: PubMed 39210725Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.
- Derived from this study: PubMed 38904251Patel-Murray NL, Zhang L, Claggett BL, Xu D, Serrano-Fernandez P, Healey M, Wandel S, Chen CW, Jacob J, Xu H, Turner GM, Chutkow W, Yates DP, O'Donnell CJ, Prescott MF, Lefkowitz M, Gimpelewicz CR, Beste MT, Zhao F, Gou L, Desai AS, Jhund PS, Packer M, Pfeffer MA, Redfield MM, Rouleau JL, Zannad F, Zile MR, McMurray JJV, Mendelson MM, Solomon SD, Cunningham JW. Aptamer Proteomics for Biomarker Discovery in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Proteomic Substudy. J Am Heart Assoc. 2024 Jul 2;13(13):e033544. doi: 10.1161/JAHA.123.033544. Epub 2024 Jun 21.
- Derived from this study: PubMed 38588927Chatur S, Neuen BL, Claggett BL, Beldhuis IE, Mc Causland FR, Desai AS, Rouleau JL, Zile MR, Lefkowitz MP, Packer M, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan Across the Spectrum of Renal Impairment in Patients With Heart Failure. J Am Coll Cardiol. 2024 Jun 4;83(22):2148-2159. doi: 10.1016/j.jacc.2024.03.392. Epub 2024 Apr 6.
- Derived from this study: PubMed 38390793Bhatt AS, Vaduganathan M, Claggett BL, Kulac IJ, Anand IS, Desai AS, Fang JC, Hernandez AF, Jhund PS, Kosiborod MN, Sabatine MS, Shah SJ, Vardeny O, McMurray JJV, Solomon SD, Gaziano TA. Cost Effectiveness of Dapagliflozin for Heart Failure Across the Spectrum of Ejection Fraction: An Economic Evaluation Based on Pooled, Individual Participant Data From the DELIVER and DAPA-HF Trials. J Am Heart Assoc. 2024 Mar 5;13(5):e032279. doi: 10.1161/JAHA.123.032279. Epub 2024 Feb 23.
- Derived from this study: PubMed 37407154Curtain JP, Adamson C, Docherty KF, Jhund PS, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJV. Prevalent and Incident Anemia in PARADIGM-HF and the Effect of Sacubitril/Valsartan. JACC Heart Fail. 2023 Jul;11(7):749-759. doi: 10.1016/j.jchf.2022.12.012. Epub 2023 Apr 12.
- Derived from this study: PubMed 37366061Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.
- Derived from this study: PubMed 37051752Tolomeo P, Butt JH, Kondo T, Campo G, Desai AS, Jhund PS, Kober L, Lefkowitz MP, Rouleau JL, Solomon SD, Swedberg K, Vaduganathan M, Zile MR, Packer M, McMurray JJV. Importance of cystatin C in estimating glomerular filtration rate: the PARADIGM-HF trial. Eur Heart J. 2023 Jun 25;44(24):2202-2212. doi: 10.1093/eurheartj/ehad210.
- Derived from this study: PubMed 36943907Butt JH, Ibrahim W, Dewan P, Desai AS, Kober L, Prescott MF, Lefkowitz MP, Rouleau JL, Solomon SD, Zile MR, Packer M, Jhund PS, McMurray JJV. Urinary cGMP (Cyclic Guanosine Monophosphate)/BNP (B-Type Natriuretic Peptide) Ratio, Sacubitril/Valsartan, and Outcomes in Heart Failure With Reduced Ejection Fraction: An Analysis of the PARADIGM-HF Trial. Circ Heart Fail. 2023 Mar;16(3):e010111. doi: 10.1161/CIRCHEARTFAILURE.122.010111. Epub 2023 Jan 25.
Related trials for Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1,031 sites in 47 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LCZ696 200 mg BID and Enalapril 10 mg BID in people with Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 1,031 sites in 47 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1,031 sites in United States, Germany, Russia, Argentina, United Kingdom and 42 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization (time frame: up to 51 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01035255, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.