Chronic Heart FailurePhase 3ATMOSPHERENCT00853658
Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
A Phase 3 study testing Enalapril and Aliskiren in people with Chronic Heart Failure, run by Novartis Pharmaceuticals at 806 sites in 44 countries.
Trial summary
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Enalapril and Aliskiren
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,064 participants
- Where
- 806 sitesin 44 countries
- Study dates
- Mar 2009to Oct 2015
- 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 eligible for inclusion in this study had to fulfill all of the following criteria:
- Patients ≥ 18 years of age, male or female.
- Patients with a diagnosis of chronic heart failure (NYHA
- Class II - IV):
- LVEF ≤ 35% at Visit 1 (local measurement, within the past 6 months assessed by echocardiography, multiple uptake gated acquisition scan (MUGA), computerized tomography(CT) scan, magnetic resonance imaging (MRI) or ventricular angiography)
- Elevated BNP or NT-proBNP at Visit 1:
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- BNP ≥ 150 pg/mL (or BNP ≥ 100 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 400 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement).
- Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to Visit 1
- Patients had to be treated with a beta-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not on target dose, according to local guidelines, or in absence of that medication, the reason should be documented).
- Written informed consent to participate in the study and ability to comply with all requirements.
Who cannot join
- Patients with any of the following were to be excluded from participation in the study:
- History of hypersensitivity to any of the study drugs including history or allergy to ACEIs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEIs during up- titration process.
- Patients treated concomitantly with both an ARB and an aldosterone antagonist in addition to study drug at Visit 1.
- Current acute decompensated HF (defined as an acute exacerbation of a chronic heart failure status manifested by typical signs and symptoms of HF like dyspnea, fatigue etc., that may require IV therapy with diuretics, vasodilators and/or inotropic drugs).
- Symptomatic hypotension and/or less than 95 mmHg systolic blood pressure (SBP) at Visit 1 and/or less than 90 mmHg SBP at Visit 4.
- Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to Visit 1.
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- Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
- Right heart failure due to severe pulmonary disease.
- Patients with Diabetes Mellitus.
Trial locations and contacts
806 sites in 44 countries.
806 sites in 44 countries
Germany97 sites
Novartis Investigative Site
Augsburg, 86150
Novartis Investigative Site
Bad Nauheim, 61231
Novartis Investigative Site
Bad Neustadt an der Saale, 97616
Novartis Investigative Site
Bensheim, 64625
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 12163
Novartis Investigative Site
Berlin, 12351
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Berlin, 12552
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Berlin, 13353
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Berlin, 13405
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Bochum, 44791
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Bonn, 53115
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Bonn, 53127
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Bonn, 53225
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Brake, 26919
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Celle, 29223
Novartis Investigative Site
Chemnitz, 09113
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Chemnitz, 09116
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Chemnitz, 09126
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Coburg, 96450
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Cologne, 51605
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Darmstadt, 64283
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Dessau, 06846
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Dinkelsbühl, 91550
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Dorsten, 46282
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Dortmund, 44137
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Dresden, 01067
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Dresden, 01097
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Dresden, 01219
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Dresden, 01277
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Dresden, 01309
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Duisburg, 47051
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Duisburg, 47139
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Düsseldorf, 40593
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Ebersbach, 02730
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Erfurt, 99084
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Erkner, 15537
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Essen, 45136
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Essen, 45355
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Frankfurt, 60594
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Gotha, 99867
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Göttingen, Germany, 37073
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Göttingen, 37075
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Gütersloh, 33332
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Halle, 06120
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Hamburg, 20099
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Hanover, 30167
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Hansestadt Salzwedel, 29410
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Haßloch, 67454
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Heidelberg, 69115
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Heidelberg, 69120
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Heilbronn, 74078
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Helmbrechts, 95223
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Heppenheim an der Bergstrasse, 64646
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Kassel, 34127
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Kleve, 47533
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Koblenz, 56068
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Königsbrück, 01436
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Köthen, 06366
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Krefeld, 47798
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Lambrecht, 67466
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Landshut, 84034
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Leipzig, 04177
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Lichtentanne, 08115
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Lienen, 49536
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Loerrach, 79539
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Ludwigsburg, 71634
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Lüneburg, 21339
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Magdeburg, 39110
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Mainz, 55116
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Markkleeberg, 04416
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Mayen, 56727
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Melsungen, 34212
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Muehldorf Am Inn, 84453
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Muehlheim An Der Ruhr, 45468
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Mülheim, 45468
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München, 80636
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Northeim, 37154
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Nuremberg, 90471
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Oelde, 59302
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Oelde, 59303
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Pirna, 01796
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Potsdam, 14471
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Reinfeld, 23858
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Schwäbisch Hall, 74523
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Schwalmstadt, 34613
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Siegen, 57072
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Solingen, 42651
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Stade, 21682
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Stuttgart, 70372
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Stuttgart, 70378
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Wedel, 22880
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Winsen, Lower Saxony, 21423
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Witten, 58455
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Würzburg, 97078
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Zwickau, 08056
United States58 sites
Novartis Investigative Site
Athens, Georgia, 30606
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Auburn, Maine, 04210
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Augusta, Georgia, 30904
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Beverly Hills, California, 90211
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Boynton Beach, Florida, 33437
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Charleston, South Carolina, 29403
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Dallas, Texas, 75226
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Daytona Beach, Florida, 32117
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Denver, Colorado, 80218
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Durham, North Carolina, 27710
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Elmer, New Jersey, 08318
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Everett, Washington, 98208
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Fort Lauderdale, Florida, 33316
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French Camp, California, 95231
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Germantown, Tennessee, 38138
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Gillespie, Illinois, 62033
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Hollywood, Florida, 33021
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77021
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Houston, Texas, 77030
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Huntsville, Alabama, 35801
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Inglewood, California, 90301
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Jacksonville Beach, Florida, 32050
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Kirkland, Washington, 98034
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Laurelton, New York, 11422
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Lincoln, Nebraska, 68506
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Little Rock, Arkansas, 72204
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Little Rock, Arkansas, 72205
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Littleton, Colorado, 80120
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Los Angeles, California, 90073
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Marion, Ohio, 43302
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Memphis, Tennessee, 38120
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Metairie, Louisiana, 70006
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Miami Lakes, Florida, 33014
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Mobile, Alabama, 36608
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Mobile, Alabama, 36693
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Modesto, California, 95355
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Nashville, Tennessee, 37205
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Nashville, Tennessee, 37212
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New Orleans, Louisiana, 70121
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Northridge, California, 91325
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Omaha, Nebraska, 68198
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Orlando, Florida, 32803
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Pine Bluff, Arkansas, 71603
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Sacramento, California, 95825
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San Diego, California, 92123
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Santa Monica, California, 90404
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Searcy, Arkansas, 72143
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Slidell, Louisiana, 70458
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Southfield, Michigan, 48075
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St Louis, Missouri, 63110
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Stony Brook, New York, 11794
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Topeka, Kansas, 66606
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Tucson, Arizona, 85723-0001
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Varnville, South Carolina, 29944
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Wellington, Florida, 33449
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Westlake Village, California, 91361
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Wiliamsville, New York, 14221
Italy48 sites
Novartis Investigative Site
Ancona, AN, 60126
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Arezzo, AR, 52100
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Bergamo, BG, 24128
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Bologna, BO, 40138
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Brescia, BS, 25123
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Casarano, LE, 73042
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Castelnuovo di Garfagnana, LU, 55032
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Cava de' Tirreni, SA, 84013
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Cecina, LI, 57023
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Chieti, CH, 66100
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Cona, FE, 44100
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Cortona, AR, 52044
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Cosenza, CS, 87100
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Cotignola, RA, 48010
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Florence, FI, 50143
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Foggia, FG, 71100
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Forlì, FC, 47100
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Lumezzane, BS, 25065
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Massa, MS, 54100
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Milan, MI, 20132
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Milan, MI, 20138
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Montescano, (pv), 27040
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Orbassano, TO, 10043
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Palermo, PA, 90127
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Parma, PR, 43100
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Passirana Di Rho, MI, 20017
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Pavia, (pv), 27100
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Pavia, PV, 27100
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Perugia, PG, 06129
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Pieve di Coriano, MN
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Poggibonsi, SI, 53036
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Pozzilli, IS, 86077
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Rimini, RN, 47900
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Roma, RM, 00169
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Roma, RM, 00184
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Roma, RM, 00189
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San Bonifacio, VR, 37047
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San Daniele del Friuli, UD, 33038
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Sarzana, SP, 19038
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Sassari, SS, 07100
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Sondalo, SO, 23035
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Terni, TR, 05100
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Torino, TO, 10126
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Tradate, VA, 21049
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Trieste, TS, 34142
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Trieste, TS, 34149
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Udine, UD, 33100
Novartis Investigative Site
Vittorio Veneto, TV, 31029
Japan46 sites
Novartis Investigative Site
Adachi-ku, Tokyo, 120-0006
Novartis Investigative Site
Amagasaki, Hyōgo, 660-8550
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8431
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8519
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Bunkyo-ku, Tokyo, 113-8603
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Bunkyo-ku, Tokyo, 113-8655
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Chiba, Chiba, 260-8677
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Chikushino-shi, Fukuoka, 818-8502
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Fukuoka, Fukuoka, 814-0180
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Fukushima, Fukushima, 960-8251
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Hamada, Shimane, 697-8511
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Higashiibaraki-gun, Ibaraki, 311-3193
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Hiroshima, Hiroshima, 734-8551
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Hitachi-Naka, Ibaraki, 312-0057
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Hōfu, Yamaguchi, 747-8511
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Iizuka, Fukuoka, 820-8505
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Inba-gun, Chiba, 270-1694
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Izumisano, Osaka, 598-8577
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Kanazawa, Ishikawa-ken, 920-8650
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Kashihara, Nara, 634-8522
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Kawasaki, Kanagawa, 210-0852
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Kita-ku, Osaka, 530-0001
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Komatsushimachō, Tokushima, 773-8502
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Kumamoto, Kumamoto, 860-8556
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Kure, Hiroshima, 737-0023
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Kurume, Fukuoka, 830-8577
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Nagasaki, Nagasaki, 850-8555
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Nagoya, Aichi-ken, 466-8560
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Ōgaki, Gifu, 503-8502
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Okayama, Okayama-ken, 702-8055
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Osaka, Osaka, 545-8586
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Saga, Saga-ken, 849-8501
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Sagamihara, Kanagawa, 252-0375
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Sapporo, Hokkaido, 060-8648
Novartis Investigative Site
Sapporo, Hokkaido, 063-0005
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Sendai, Miyagi, 980-8574
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Seto, Aichi-ken, 489-8642
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Shinjuku-ku, Tokyo, 162-8666
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Shūnan, Yamaguchi, 745-8522
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Tokushima, Tokushima, 770-8503
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Toyama, Toyama, 930-0194
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Tsukuba, Ibaraki, 305-8576
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Ube, Yamaguchi, 755-8505
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Ureshino, Saga-ken, 843-0393
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Yokohama, Kanagawa, 232-0024
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Yokosuka, Kanagawa, 238-8567
Russia45 sites
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Barnaul, 656055
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Chelyabinsk, 454000
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Chelyabinsk, 454021
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Chelyabinsk, 454047
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Chelyabinsk, 454048
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Izhevsk, 426009
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Kirov, 610014
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Krasnodar, 350063
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Kursk, 305035
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Lyubertsy, 140006
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Moscow, 105229
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Moscow, 111020
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Moscow, 111539
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Moscow, 115432
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Moscow, 117292
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Moscow, 119992
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Moscow, 121359
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Moscow, 127473
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Moscow, 129301
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Moscow
Novartis Investigative Site
Nizhny Novgorod, 603018
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Novosibirsk, 630047
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Novosibirsk, 630075
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Novosibirsk, 630089
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Omsk, 644018
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Perm, 614097
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Pushkin,St-Petersburg, 196601
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Ryazan, 390026
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S.-Petersburg, 196247
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Saint Petersburg, 191119
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Saint Petersburg, 194044
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Saint Petersburg, 197022
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Saint Petersburg, 197341
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Saint Petersburg, 198013
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Saratov, 410012
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Saratov, 410028
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Tyumen, 625026
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Volgograd, 400001
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Volgograd, 400008
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Voronezh, 394065
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Yaroslavl, 150000
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Yaroslavl, 150030
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Yaroslavl, 150062
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Yekaterinburg, 620028
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Yekaterinburg, 620137
India38 sites
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Ahmedabad, Gujarat, 380 051
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Bangalore, Karnataka, 560 052
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Bangalore, Karnataka, 560099
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Bangalore, 560 034
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Chennai, Tamil Nadu, 600100
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Coimbatore, Tamil Nadu, 641014
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Delhi, New Delhi, 110065
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Guntur, Andhra Pradesh, 522001
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Hyderabad, Andhra Pradesh, 500012
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Hyderabad, Telangana, 500082
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Hyderabad, 500 063
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Hyderabad, 500044
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Jaipur, Rajasthan, 302001
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Jaipur, Rajasthan, 302024
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Lucknow, India, 226003
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Lucknow, Uttar Pradesh, 226005
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Lucknow, Uttar Pradesh, 226014
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Madurai, Tamil Nadu, 625107
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Manipal, Karnataka, 576104
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Mumbai, India, 400 050
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Mumbai, Maharashtra, 400 022
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Nagpur, Maharashtra, 400 008
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Nagpur, Maharashtra, 400 012
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Nagpur, Maharashtra, 400012
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Nagpur, Maharashtra, 440 010
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Nagpur, Maharashtra, 440010
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Nagpur, Maharashtra, 440012
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New Delhi, National Capital Territory of Delhi, 110060
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New Delhi, New Delhi, 110044
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Noida, India, 201301
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Pune, Maharashtra, 411 011
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Pune, Maharashtra, 411 019
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Pune, Maharashtra, 411 044
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Pune, Maharashtra, 411004
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Pune, Maharashtra, 411011
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Secunderabad, Andhra Pradesh, 500003
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Trivandrum, Kerala, 695002
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Vijayawada, Andhra Pradesh, 520 008
Argentina37 sites
Novartis Investigative Site
Bahía Blanca, Buenos Aires, 8000
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1094AAD
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1428DCO
Novartis Investigative Site
Caba, Buenos Aires, C1180AAX
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Caba, Buenos Aires, C1408INH
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Caba, Buenos Aires, C1416DRJ
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Córdoba, Córdoba Province, X5000AAI
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Córdoba, Córdoba Province, X5000AVI
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Córdoba, Córdoba Province, X5000EPU
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Córdoba, Córdoba Province, X5000EVQ
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Córdoba, Córdoba Province, X5000FGG
Novartis Investigative Site
Córdoba, Córdoba Province, X5002AOQ
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Córdoba, Córdoba Province, X5003DCE
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Córdoba, Córdoba Province, X5004BAL
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Córdoba, Córdoba Province, X5006IKK
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Córdoba, Córdoba Province, X5009BSN
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Córdoba, Córdoba Province, X5022CPU
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Córdoba, Córdoba Province, X5152HQC
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Córdoba, Córdoba Province, X5220XAO
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Coronel Suárez, Buenos Aires, B7540GHD
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Corrientes, Corrientes Province, W3400CBI
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Corrientes, Corrientes Province, W3400
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La Plata, Buenos Aires, 1900
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Posadas, Misiones Province, N3300AHX
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Quilmes, Buenos Aires, B1878GEG
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Ramos Mejía, Buenos Aires, B1704ETD
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Rosario, Santa Fe Province, S2000CXH
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Rosario, Santa Fe Province, S2000DFD
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Rosario, Santa Fe Province, S2000DSV
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Rosario, Santa Fe Province, S2001ODA
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Salta, Salta Province, 4400
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San Isidro, Buenos Aires, B1642DCD
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San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL
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San Miguel de Tucumán, Tucumán Province, T4000IFL
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San Nicolás de los Arroyos, Buenos Aires, B2900DMH
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Va Allende, Córdoba Province, 5105
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Villa María, Córdoba Province, X5220XAO
China33 sites
Novartis Investigative Site
Baotou, 014040
Novartis Investigative Site
Beijing, Beijing Municipality, 100083
Novartis Investigative Site
Beijing, Beijing Municipality, 100088
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Beijing, 100020
Novartis Investigative Site
Beijing, 100028
Novartis Investigative Site
Beijing, 100029
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Beijing, 100044
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Fuzhou, Fujian, 350001
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Novartis Investigative Site
Guangzhou, Guangdong, 510515
Novartis Investigative Site
Guangzhou, 510080
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Hangzhou, Zhejiang, 310009
Novartis Investigative Site
Hangzhou, Zhejiang, 310013
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Jinan, 250012
Novartis Investigative Site
Nanjing, Jiangsu
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200011
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanghai, 200032
Novartis Investigative Site
Shanghai, 200233
Novartis Investigative Site
Shenyang, Liaoning, 110003
Novartis Investigative Site
Shenyang, Liaoning, 110016
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
Novartis Investigative Site
Suzhou, Jiangsu, 215004
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300121
Novartis Investigative Site
Tianjin, 300142
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Xi'an, 710004
Poland30 sites
Novartis Investigative Site
Bytom, 41-902
Novartis Investigative Site
Chorzów, 41-506
Novartis Investigative Site
Gdansk, 80-180
Novartis Investigative Site
Gdynia, 81-423
Novartis Investigative Site
Gdynia, 81-519
Novartis Investigative Site
Gliwice, 44-100
Novartis Investigative Site
Grodzisk Mazowiecki, 05-825
Novartis Investigative Site
Katowice, 40-040
Novartis Investigative Site
Katowice, 40-084
Novartis Investigative Site
Kłodzko, 57-300
Novartis Investigative Site
Krakow, 30-053
Novartis Investigative Site
Krakow, 31-501
Novartis Investigative Site
Łomża, 18-104
Novartis Investigative Site
Oława, 55-200
Novartis Investigative Site
Opole, 45-706
Novartis Investigative Site
Ostrów Wielkopolski, 63-400
Novartis Investigative Site
Ostrowiec Świętokrzyski, 27-400
Novartis Investigative Site
Piotrkow Trybunalski, 97-300
Novartis Investigative Site
Płock, 09-402
Novartis Investigative Site
Poznan, 61-485
Novartis Investigative Site
Sandomierz, 27-600
Novartis Investigative Site
Tarnów, 33-100
Novartis Investigative Site
Torun, 87-100
Novartis Investigative Site
Warsaw, 03-242
Novartis Investigative Site
Warsaw, 04-628
Novartis Investigative Site
Wroclaw, 50-349
Novartis Investigative Site
Wroclaw, 50-420
Novartis Investigative Site
Wroclaw, 50-981
Novartis Investigative Site
Wroclaw, 52-612
Novartis Investigative Site
Zabrze, 41-800
Denmark22 sites
Novartis Investigative Site
Aalborg, Denmark, DK-9000
Novartis Investigative Site
Århus N, DK-8200
Novartis Investigative Site
Copenhagen, 2100
Novartis Investigative Site
Copenhagen NV, DK-2400
Novartis Investigative Site
Copenhagen S, DK-2300
Novartis Investigative Site
Elsinore, DK-3000
Novartis Investigative Site
Esbjerg, DK-6700
Novartis Investigative Site
Fredericia, 7000
Novartis Investigative Site
Frederiksberg, DK-2000
Novartis Investigative Site
Glostrup Municipality, DK-2600
Novartis Investigative Site
Hellerup, Denmark, DK-2900
Novartis Investigative Site
Hillerød, DK-3400
Novartis Investigative Site
Hjørring, DK-9800
Novartis Investigative Site
Holbæk, DK-4300
Novartis Investigative Site
Hvidovre, Denmark, DK-2650
Novartis Investigative Site
Køge, DK-4600
Novartis Investigative Site
Næstved, DK-4700
Novartis Investigative Site
Odense C, DK-5000
Novartis Investigative Site
Randers NØ, DK-8930
Novartis Investigative Site
Silkeborg, Denmark, 8600
Novartis Investigative Site
Svendborg, DK-5700
Novartis Investigative Site
Viborg, DK-8800
Slovakia22 sites
Novartis Investigative Site
Bardejov, Slovakia, 085 01
Novartis Investigative Site
Bratislava, Slovak Republic, 812 72
Novartis Investigative Site
Bratislava, Slovak Republic, 826 06
Novartis Investigative Site
Bratislava, 81369
Novartis Investigative Site
Komárno, Slovak Republic, 94575
Novartis Investigative Site
Košice, Slovak Republic, 040 01
Novartis Investigative Site
Košice, Slovak Republic, 04166
Novartis Investigative Site
Košice, Slovakia, 040 01
Novartis Investigative Site
Košice, Slovakia, 04001
Novartis Investigative Site
Levice, Slovak Republic, 93401
Novartis Investigative Site
Lučenec, Slovakia, 98439
Novartis Investigative Site
Nitra, Slovak Republic, 949 01
Novartis Investigative Site
Piešťany, 921 01
Novartis Investigative Site
Považská Bystrica, Slovak Republic, 01701
Novartis Investigative Site
Prešov, Slovak Republic, 08101
Novartis Investigative Site
Prešov, Slovakia, 080 01
Novartis Investigative Site
Stropkov, Slovak Republic, 09101
Novartis Investigative Site
Trebišov, Slovakia, 075 01
Novartis Investigative Site
Trenčín, Slovakia, 911 01
Novartis Investigative Site
Žilina, Slovak Republic, 010 01
Novartis Investigative Site
Žilina, Slovak Republic, 08001
Novartis Investigative Site
Žilina, 012 07
Spain22 sites
Novartis Investigative Site
Alicante, Valencia, 03004
Novartis Investigative Site
Badalona, Catalonia, 08916
Novartis Investigative Site
Barcelona, Barcelona, 08041
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, Madrid, 28007
Novartis Investigative Site
Madrid, Madrid, 28040
Novartis Investigative Site
Madrid, Madrid, 28041
Novartis Investigative Site
Madrid, Madrid, 28046
Novartis Investigative Site
Madrid, Madrid, 28049
Novartis Investigative Site
Majadahonda, Madrid, 28222
Novartis Investigative Site
Oviedo, Principality of Asturias, 33011
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Tarragona, Catalonia, 43005
Novartis Investigative Site
Tortosa, Catalonia, 43500
Novartis Investigative Site
Utrera, Andalusia, 41710
Novartis Investigative Site
Valdemoro, Madrid, 28342
Novartis Investigative Site
Valencia, Valencia, 46014
Novartis Investigative Site
Villamartín, Cadiz, 11650
Brazil21 sites
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30110-934
Novartis Investigative Site
Belo Horizonte, Minas Gerais
Novartis Investigative Site
Brasília, Federal District, 70658-700
Novartis Investigative Site
Campina Grande do Sul, Paraná, 83430-000
Novartis Investigative Site
Campinas, São Paulo, 13020-431
Novartis Investigative Site
Campinas, São Paulo, 13060-904
Novartis Investigative Site
Campinas, São Paulo, 13083-190
Novartis Investigative Site
Caxias do Sul, Rio Grande do Sul, 95070-560
Novartis Investigative Site
Curitiba, Paraná, 80010-030
Novartis Investigative Site
Fortaleza, Ceará, 60864-190
Novartis Investigative Site
Goiânia, Goiás, 74605-050
Novartis Investigative Site
Londrina, Paraná, 86051-990
Novartis Investigative Site
Marília, São Paulo, 17519-030
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-903
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90560-030
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-000
Novartis Investigative Site
Recife, Pernambuco, 50100-060
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 22240-006
Novartis Investigative Site
São Paulo, São Paulo, 05403-900
Novartis Investigative Site
Tatuí, São Paulo, 18270-170
Netherlands21 sites
Novartis Investigative Site
Alkmaar, 1815 JD
Novartis Investigative Site
Amsterdam, 1023 NL
Novartis Investigative Site
Amsterdam, 1061 AE
Novartis Investigative Site
Amsterdam, 1091 HA
Novartis Investigative Site
Amsterdam, 1105 AZ
Novartis Investigative Site
Apeldoorn, 7334 DZ
Novartis Investigative Site
Deventer, 7416 SE
Novartis Investigative Site
Dirksland, 3247 BW
Novartis Investigative Site
Enschede, Netherlands, 7513 ER
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Haarlem, 2035 RC
Novartis Investigative Site
Heerlen, 6419 PC
Novartis Investigative Site
Leeuwarden, 8934 AD
Novartis Investigative Site
Leiderdorp, NL-2353 GA
Novartis Investigative Site
Meppel, 7943 KA
Novartis Investigative Site
Rotterdam, 3045 PM
Novartis Investigative Site
Rotterdam, 3083 AN
Novartis Investigative Site
Venlo, 5912 BL
Novartis Investigative Site
Wildervank, 9648 BE
Novartis Investigative Site
Zutphen, Netherlands, 7207 AE
Novartis Investigative Site
Zwolle, 8011 JW
Sweden21 sites
Novartis Investigative Site
Falun, 791 82
Novartis Investigative Site
Gothenburg, 416 85
Novartis Investigative Site
Karlstad, 681 85
Novartis Investigative Site
Linköping, 581 85
Novartis Investigative Site
Lund, SE-222 21
Novartis Investigative Site
Malmö, Sweden, SE 211 36
Novartis Investigative Site
Malmö, 205 02
Novartis Investigative Site
Malmö, 214 22
Novartis Investigative Site
Mölndal, 431 80
Novartis Investigative Site
Nässjö, Sweden, SE 571 31
Novartis Investigative Site
Örebro, 701 85
Novartis Investigative Site
Skellefteå, 931 86
Novartis Investigative Site
Stockholm, 111 57
Novartis Investigative Site
Stockholm, 112 81
Novartis Investigative Site
Stockholm, 17176
Novartis Investigative Site
Stockholm, SE-111 35
Novartis Investigative Site
Sundsvall, 851 86
Novartis Investigative Site
Sundsvall, 852 31
Novartis Investigative Site
Umeå, 901 85
Novartis Investigative Site
Uppsala, SE-751 85
Novartis Investigative Site
Västerås, s-721 89
Romania18 sites
Novartis Investigative Site
Baia Mare, 430123
Novartis Investigative Site
Brasov, Romania, 500281
Novartis Investigative Site
Brasov, Romania, 500427
Novartis Investigative Site
Bucharest, District 1, 012051
Novartis Investigative Site
Bucharest, District 1, 012064
Novartis Investigative Site
Bucharest, District 2, 021705
Novartis Investigative Site
Cluj-Napoca, 400006
Novartis Investigative Site
Cluj-Napoca, 400347
Novartis Investigative Site
Iași, Jud Iasi, 700005
Novartis Investigative Site
Iași, Jud. Iasi, 700506
Novartis Investigative Site
Iași, 700547
Novartis Investigative Site
Oradea, Romania, 410169
Novartis Investigative Site
Piteşti, 110114
Novartis Investigative Site
Târgu Mureş, Jud Mures, 540043
Novartis Investigative Site
Târgu Mureş, Mureș County, 540136
Novartis Investigative Site
Târgu Mureş, 540096
Novartis Investigative Site
Timișoara, Romania, 300736
Novartis Investigative Site
Timișoara, 300310
Czechia17 sites
Novartis Investigative Site
Benešov, Czech Republic, 25601
Novartis Investigative Site
Brno, Czech Republic, 60200
Novartis Investigative Site
Český Krumlov, Czech Republic, 381 01
Novartis Investigative Site
Jindřichův Hradec, Czech Republic, 377 01
Novartis Investigative Site
Kolín, Czech Republic, 280 02
Novartis Investigative Site
Kroměříž, Czech Republic, 767 01
Novartis Investigative Site
Louny, Czech Republic, 440 01
Novartis Investigative Site
Louny, Czech Republic
Novartis Investigative Site
Mariánské Lázně, 353 01
Novartis Investigative Site
Ostrava, Czech Republic, 70200
Novartis Investigative Site
Pilsen, Czech Republic, 323 00
Novartis Investigative Site
Prague, Czech Republic, 148 00
Novartis Investigative Site
Prague, Czech Republic
Novartis Investigative Site
Prague, 128 08
Novartis Investigative Site
Pribram VIII, 261 01
Novartis Investigative Site
Teplice, Czech Republic, 415 01
Novartis Investigative Site
Vyškov, Czech Republic, 68001
United Kingdom16 sites
Novartis Investigative Site
Addlestone, Surrey, KT15 2BH
Novartis Investigative Site
Cardiff, CF5 4AD
Novartis Investigative Site
Chesterfield, S44 5BL
Novartis Investigative Site
Chichester, West Sussex, PO19 6SE
Novartis Investigative Site
Colchester, CO4 5JL
Novartis Investigative Site
Dafen, Llanelli, SA14 8QF
Novartis Investigative Site
East Yorkshire, HU16 5JQ
Novartis Investigative Site
Glasgow, G51 4TF
Novartis Investigative Site
Leicester, Leicestershire, LE3 9QP
Novartis Investigative Site
Liverpool, L14 3PE
Novartis Investigative Site
London, SE1 7EH
Novartis Investigative Site
London, SW17 0RE
Novartis Investigative Site
Manchester, M23 9LT
Novartis Investigative Site
Southampton, SO16 6YD
Novartis Investigative Site
Swindon, SN3 6BB
Novartis Investigative Site
Worthing, West Sussex, BN11 2DH
France13 sites
Novartis Investigative Site
Albi, 81013
Novartis Investigative Site
Angers, 49000
Novartis Investigative Site
Bécon-les-Granits, 49370
Novartis Investigative Site
Clichy, 92110
Novartis Investigative Site
Dijon, 21079
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Marseille, 13385
Novartis Investigative Site
Marseille, 13915
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Paris, 75571
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Saint-Etienne, 42055
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Belgium12 sites
Novartis Investigative Site
Anderlecht, 1070
Novartis Investigative Site
Bruges, 8000
Novartis Investigative Site
Brussels, Belgium, 1180
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
De Pinte, 9840
Novartis Investigative Site
Eupen, 4700
Novartis Investigative Site
Genk, 3600
Novartis Investigative Site
Huy, 4500
Novartis Investigative Site
Ieper, 8900
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Novartis Investigative Site
Turnhout, 2300
South Korea12 sites
Novartis Investigative Site
Busan, 602-715
Novartis Investigative Site
Daejeon, 302-241
Novartis Investigative Site
Gwangju, Gwangju, 501-757
Novartis Investigative Site
Incheon, 405-760
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620
Novartis Investigative Site
Seoul, Korea, 03080
Novartis Investigative Site
Seoul, Korea, 03722
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Korea, 152-703
Novartis Investigative Site
Seoul, 143-729
Novartis Investigative Site
Taegu, 700 - 721
Australia11 sites
Novartis Investigative Site
Auchenflower, Queensland, 4066
Novartis Investigative Site
Bedford Park, South Australia, 5042
Novartis Investigative Site
Canberra, Australian Capital Territory, 2605
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
Novartis Investigative Site
Geelong, Victoria, 3220
Novartis Investigative Site
Kingswood, New South Wales, 2747
Novartis Investigative Site
Launceston, Tasmania, 7250
Novartis Investigative Site
Prahran, Victoria, 3181
Novartis Investigative Site
Wollongong, New South Wales, 2500
Novartis Investigative Site
Woolloongabba, Queensland, 4101
Novartis Investigative Site
Wooloongabba, Queensland, 4102
Colombia11 sites
Novartis Investigative Site
Baranquilla, Atlántico
Novartis Investigative Site
Barranquilla, Atlántico
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogota, Cundinamarca, 111411
Novartis Investigative Site
Bogotá, Cundinamarca, 110111
Novartis Investigative Site
Bogotá, 00000
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Cartagena, Departamento de Bolívar
Novartis Investigative Site
Florida Blanca
Novartis Investigative Site
Medellín, Antioquia
Novartis Investigative Site
Medellín
Canada10 sites
Novartis Investigative Site
Brampton, Ontario, L6Z 4N5
Novartis Investigative Site
Calgary, Alberta, T2N 4Z6
Novartis Investigative Site
Cambridge, Ontario, N1R 6V6
Novartis Investigative Site
Joliette, Quebec, J6E 6J2
Novartis Investigative Site
Montreal, Quebec, H1T 1C8
Novartis Investigative Site
Montreal, Quebec, H1T 3Y7
Novartis Investigative Site
Ottawa, Ontario, K1Y 4W7
Novartis Investigative Site
Québec, Quebec, G1J 1Z6
Novartis Investigative Site
Saint John, New Brunswick, E2L 4L2
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5
Peru10 sites
Novartis Investigative Site
Bellavista, Lima region, Callao 02
Novartis Investigative Site
Chiclayo, Lambayeque
Novartis Investigative Site
Jesus Maria, Lima region, 11
Novartis Investigative Site
Lima, Lima Province, Lima 39
Novartis Investigative Site
Lima Cercado, Lima region, 01
Novartis Investigative Site
Miraflores, Lima region, 18
Novartis Investigative Site
San Borja, Lima region, 41
Novartis Investigative Site
San Isidro, Lima region, 27
Novartis Investigative Site
San Juan de Miraflores, Lima region, 29
Novartis Investigative Site
Trujillo, La Libertad
Portugal10 sites
Novartis Investigative Site
Amadora, Portugal, 2720-276
Novartis Investigative Site
Aveiro, 3814-501
Novartis Investigative Site
Carnaxide, Portugal, 2799-523
Novartis Investigative Site
Coimbra, Portugal, 3000-075
Novartis Investigative Site
Faro, 8000-386
Novartis Investigative Site
Lisbon, Portugal, 1495-005
Novartis Investigative Site
Lisbon, Portugal, 1600-190
Novartis Investigative Site
Lisbon, Portugal, 1769-001
Novartis Investigative Site
Penafiel, Portugal, 4564-007
Novartis Investigative Site
Porto, Portugal, 4200-319
Turkey (Türkiye)10 sites
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Aydin, Turkey, 09100
Novartis Investigative Site
Balcova / Izmir, 35340
Novartis Investigative Site
Etlik / Ankara, 06018
Novartis Investigative Site
Fatih / Istanbul, 34098
Novartis Investigative Site
Istanbul, Turkey, 34304
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Kinikli / Denizli, 20070
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Sivas, 58140
Austria9 sites
Novartis Investigative Site
Graz, Austria, A-8036
Novartis Investigative Site
Innsbruck, Tyrol, 6020
Novartis Investigative Site
Linz, 4010
Novartis Investigative Site
Linz, A-4010
Novartis Investigative Site
Salzburg, A-5020
Novartis Investigative Site
Vienna, 1030
Novartis Investigative Site
Vienna, 1140
Novartis Investigative Site
Vienna, A-1090
Novartis Investigative Site
Vienna, A-1160
Switzerland9 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Bellinzona, 6500
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Biel, 2500
Novartis Investigative Site
Bruderholz, 4101
Novartis Investigative Site
Lugano, 6903
Novartis Investigative Site
Olten, 4600
Novartis Investigative Site
Winterthur, 8401
Novartis Investigative Site
Zurich, 8091
Venezuela9 sites
Novartis Investigative Site
Barcelona, Anzoátegui, 6001
Novartis Investigative Site
Caracas, Distrito Federal, 1010
Novartis Investigative Site
Caracas, Distrito Federal, 1040
Novartis Investigative Site
Caracas, Distrito Federal, 1060
Novartis Investigative Site
Caracas, Miranda, 1061
Novartis Investigative Site
Cumaná, Sucre, 6101
Novartis Investigative Site
Maracaibo, Zulia, 4011
Novartis Investigative Site
Puerto Ordaz and San Felix, Bolívar, 8050
Novartis Investigative Site
Valencia, Edo. Carabobo, 2001
Greece8 sites
Novartis Investigative Site
Athens, Greece, 124 62
Novartis Investigative Site
Athens, Greece, GR 11527
Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Athens, 115 28
Novartis Investigative Site
Chios, 82100
Novartis Investigative Site
Edessa, 58200
Novartis Investigative Site
Thessaloniki, GR, 546 36
Novartis Investigative Site
Thessaloniki, GR, 570 10
Mexico8 sites
Novartis Investigative Site
Aguascalientes, Aguascalientes, 20230
Novartis Investigative Site
Culiacán, Sinaloa, CP:83230
Novartis Investigative Site
Guadalajara, Jalisco, 44600
Novartis Investigative Site
Monterrey, Nuevo León, 64060
Novartis Investigative Site
Monterrey, Nuevo León, 64710
Novartis Investigative Site
Querétaro City, Querétaro, 76000
Novartis Investigative Site
San Luis Potosí City, San Luis Potosí, 78200
Novartis Investigative Site
Zapopan, Jalisco, 45200
Taiwan8 sites
Novartis Investigative Site
Kaohsiung City, 807
Novartis Investigative Site
Linkou District, 33305
Novartis Investigative Site
Niaosong Township, Taiwan, 83301
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Tainan, Taiwan ROC, 70403
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, 104
Novartis Investigative Site
Yongkang District, Tainan, 71004
South Africa7 sites
Novartis Investigative Site
Benoni
Novartis Investigative Site
Boksburg
Novartis Investigative Site
Centurion, 4001
Novartis Investigative Site
Johannesburg, 2157
Novartis Investigative Site
Soweto, Gauteng, 2013
Novartis Investigative Site
Western Cape, 7130
Novartis Investigative Site
Worcester, 6850
Finland5 sites
Novartis Investigative Site
Ekenäs, 10600
Novartis Investigative Site
Hyvinkää, FIN-05850
Novartis Investigative Site
Jyväskylä, FIN-40620
Novartis Investigative Site
Seinäjoki, Finland, 60200
Novartis Investigative Site
Turku, FIN-20520
Costa Rica4 sites
Novartis Investigative Site
Alajuela, Costa Rica
Novartis Investigative Site
Guadalupe, San Jose, Costa Rica, 3184-1000
Novartis Investigative Site
San José, Costa Rica, 1307-1000
Novartis Investigative Site
San José, Costa Rica, 272-1225
Estonia4 sites
Novartis Investigative Site
Pärnu, 80010
Novartis Investigative Site
Tallinn, Estonia, 10138
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, 51014
Ireland4 sites
Novartis Investigative Site
Co Dublin, Ireland
Novartis Investigative Site
Dublin, 9
Novartis Investigative Site
Dublin
Novartis Investigative Site
Galway, Ireland
Latvia4 sites
Novartis Investigative Site
Daugavpils, LV-5401
Novartis Investigative Site
Riga, 1012
Novartis Investigative Site
Riga, LV-1012
Novartis Investigative Site
Riga, LV-1038
Lithuania4 sites
Novartis Investigative Site
Kaunas, LTU, 50009
Novartis Investigative Site
Kaunas, LT-47144
Novartis Investigative Site
Klaipėda, LT-92288
Novartis Investigative Site
Vilnius, 08661
Thailand4 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200
Norway3 sites
Novartis Investigative Site
Oslo, 0514
Novartis Investigative Site
Tønsberg, 3116
Novartis Investigative Site
Trondheim, 7006
Puerto Rico3 sites
Novartis Investigative Site
Humacao, 00791
Novartis Investigative Site
Ponce, 00717
Novartis Investigative Site
San Juan, 00936-6528
Dominican Republic2 sites
Novartis Investigative Site
San Cristobal, San Cristóbal
Novartis Investigative Site
Santo Domingo, Republica Dominicana
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
- Conditions
- Chronic Heart Failure
- Being tested
- Enalapril, Aliskiren
- Keywords
- Chronic Heart Failure, Cardiovascular death, CHF hospitalization, morbi-mortality trial, outcome study, endpoint driven, plasma renin activity, renin angiotensin aldosterone system, direct renin inhibitors, BNP, KCCQ, eGFR, (NYHA class II to IV) with elevated, BNP and reduced LVEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
Enalapril 10 mg film-coated tablet and administered orally.
AliskirenDrug
Also called SPP100
Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Combination Aliskiren / Enalapril | Experimental | Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally. Receives: Drug: Enalapril; Drug: Aliskiren |
| Aliskiren | Experimental | Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally. Receives: Drug: Aliskiren |
| Enalapril | Active comparator | Enalapril monotherapy -10 mg film-coated tablet and administered orally. Receives: Drug: Enalapril |
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 End of Study (78 months)
Secondary outcomes (2)
Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Change from baseline to Month 12 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 12
All Cause Death
Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.
Measured: up to end of study (78 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2015
- Study completionOct 2015
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 (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7,064 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
- NCT00853658
- Sponsor's protocol ID
- CSPP100F2301
- Other IDs
- 2008-004104-31, 2008
- Acronym
- ATMOSPHERE
- Status last verified
- Oct 2016
- First submitted
- 26 Feb 2009
- Last updated
- 25 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Patel-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 38904251Kondo 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 37366061Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Kober LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.
PubMed 34101002Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
PubMed 33089502Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rorth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators.. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.
PubMed 32720404Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Bohm M, Desai AS, Dickstein K, Kober LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.
PubMed 31849164Dewan P, Rorth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9.
PubMed 31813280Shen L, Ramires F, Martinez F, Bodanese LC, Echeverria LE, Gomez EA, Abraham WT, Dickstein K, Kober L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11):e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.
PubMed 29141857Kristensen SL, Jhund PS, Mogensen UM, Rorth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10):e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.
PubMed 29018174Kristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJV, Kober L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail. 2018 Jan;20(1):136-147. doi: 10.1002/ejhf.896. Epub 2017 Sep 25.
PubMed 28948656McMurray JJ, Krum H, Abraham WT, Dickstein K, Kober LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med. 2016 Apr 21;374(16):1521-32. doi: 10.1056/NEJMoa1514859. Epub 2016 Apr 4.
PubMed 27043774
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 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 Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).
- ClinicalTrials.gov ID
- NCT00853658
- Acronym / sponsor ID
- ATMOSPHERE / CSPP100F2301
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart Failure, Cardiovascular death, CHF hospitalization, morbi-mortality trial, outcome study, endpoint driven, plasma renin activity, renin angiotensin aldosterone system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,064 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 25 Nov 2016
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 both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination Aliskiren / Enalapril | Experimental | Drug: Enalapril, Drug: AliskirenAliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally. |
| Aliskiren | Experimental | Drug: AliskirenAliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally. |
| Enalapril | Active comparator | Drug: EnalaprilEnalapril monotherapy -10 mg film-coated tablet and administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients eligible for inclusion in this study had to fulfill all of the following criteria:
- Patients ≥ 18 years of age, male or female.
- Patients with a diagnosis of chronic heart failure (NYHA
- BNP ≥ 150 pg/mL (or BNP ≥ 100 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 400 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement).
- Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to Visit 1
Key exclusion criteria (9 listed)
- History of hypersensitivity to any of the study drugs including history or allergy to ACEIs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEIs during up- titration process.
- Patients treated concomitantly with both an ARB and an aldosterone antagonist in addition to study drug at Visit 1.
- Current acute decompensated HF (defined as an acute exacerbation of a chronic heart failure status manifested by typical signs and symptoms of HF like dyspnea, fatigue etc., that may require IV therapy with diuretics, vasodilators and/or inotropic drugs).
- Symptomatic hypotension and/or less than 95 mmHg systolic blood pressure (SBP) at Visit 1 and/or less than 90 mmHg SBP at Visit 4.
- Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to Visit 1.
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 |
|---|---|---|
| EnalaprilEnalapril 10 mg film-coated tablet and administered orally. | Drug | Combination Aliskiren / Enalapril, Enalapril |
| AliskirenAlso: SPP100Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally. | Drug | Aliskiren, Combination Aliskiren / 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 End of Study (78 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.
2 secondary outcomes
Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Time frame: Baseline, Month 12
All Cause Death
Time frame: up to end of study (78 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 34101002Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Kober LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.
- Derived from this study: PubMed 33089502Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
- Derived from this study: PubMed 32720404Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rorth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators.. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.
- Derived from this study: PubMed 31849164Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Bohm M, Desai AS, Dickstein K, Kober LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.
- Derived from this study: PubMed 31813280Dewan P, Rorth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9.
- Derived from this study: PubMed 29141857Shen L, Ramires F, Martinez F, Bodanese LC, Echeverria LE, Gomez EA, Abraham WT, Dickstein K, Kober L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11):e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.
- Derived from this study: PubMed 29018174Kristensen SL, Jhund PS, Mogensen UM, Rorth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10):e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.
- Derived from this study: PubMed 28948656Kristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJV, Kober L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail. 2018 Jan;20(1):136-147. doi: 10.1002/ejhf.896. Epub 2017 Sep 25.
- Derived from this study: PubMed 27043774McMurray JJ, Krum H, Abraham WT, Dickstein K, Kober LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med. 2016 Apr 21;374(16):1521-32. doi: 10.1056/NEJMoa1514859. Epub 2016 Apr 4.
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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
806 sites in 44 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enalapril and Aliskiren in people with Chronic Heart Failure, run by Novartis Pharmaceuticals at 806 sites in 44 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 806 sites in Germany, United States, Italy, Japan, Russia and 39 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 25 Nov 2016). 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 End of Study (78 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 NCT00853658, which also lists 11 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 25 Nov 2016.