AzTrials
AzTrials

Heart Failure With Reduced Ejection Fraction (HF-rEF)NCT02389933

Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

A study testing LCZ696 in people with Heart Failure With Reduced Ejection Fraction (HF-rEF), run by Novartis Pharmaceuticals at 286 sites in 18 countries.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LCZ696
Type of treatment
Pill or oral medicine
How many people
Not given
Where
286 sitesin 18 countries
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

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

  • The patient(s) for whom the MPP is sought meets all of the following:
  • Is suffering from a serious or life-threatening disease or condition
  • Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)
  • Patient should be on optimized standard of care treatment, including treatment with ARBs or ACEI, beta-blockers and MRA;
  • Intolerance to evidence-based target doses should be documented by the treating physician
  • Meets any other relevant medical criteria for compassionate use of the investigational product
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  • Patients eligible for inclusion in this program have to fulfill all of the following criteria:
  • Adult patients (but not younger than 18 year old) will be included, upon completion of written informed consent before any assessment is performed.
  • Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction:
  • LVEF ≤ 35% at the time of screening for participation in the program (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided there are no subsequent measurement above 35%)
  • Patient had a hospitalization for HF within the last 12 months
  • Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior to starting treatment with LCZ696
  • Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 (reason should be documented for patients not on CHF target doses per local guidelines, or in absence of that medication).
  • An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to starting treatment with LCZ696

Who cannot join

  • Patients fulfilling any of the following criteria are not eligible for inclusion in this program:
  • The patient is eligible for participation in any of the IMP's ongoing clinical trials
  • The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment.
  • The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation
  • History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or NEP inhibitors; as well as known or suspected contraindications to LCZ696
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
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  • Previous history of intolerance to recommended target doses of ARBs
  • Known history of angioedema
  • Requirement of concomitant treatment with both ACEIs and ARBs
  • Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
  • Symptomatic hypotension and/or a SBP less than 100 mm Hg over the last 4 weeks prior to starting treatment with LCZ696
  • Estimated GFR below 30 mL/min/1.73m2 as measured by the simplified MDRD formula
  • Presence of bilateral renal artery stenosis
  • Serum potassium above 5.2 mmol/L during the week prior to starting treatment with LCZ696
  • Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to starting treatment with LCZ696
  • Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after the schedule date to start treatment with LCZ696
  • Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to starting treatment with LCZ696, or intent to implant such a device.
  • Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before starting treatment with LCZ696 are excluded.
  • Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD
  • History of severe pulmonary disease
  • Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to starting treatment with LCZ696
  • Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to starting treatment with LCZ696
  • Symptomatic bradycardia or second or third degree heart block without a pacemaker
  • Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation
  • Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following:
  • History of active inflammatory bowel disease during the 12 months before starting treatment with LCZ696.
  • Current duodenal or gastric ulcers during the 3 months prior to starting treatment with LCZ696
  • Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
  • Active treatment with cholestyramine or colestipol resins
  • Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (above 5 mIU/mL)
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by the local regulatory authority and ethics committee) or a barrier method plus a hormonal method
  • Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progesterone agent.
  • Reliable contraception should be maintained throughout the treatment and for 7 days after LCZ696 treatment discontinuation
  • Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea, or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Presence of any other disease with a life expectancy of < 3 years
  • Any condition, not identified in the protocol that in the opinion of the treating physician is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the therapy.

Trial locations and contacts

286 sites in 18 countries.

286 sites in 18 countries

France92 sites

  • Novartis Investigative Site

    Amiens, 80054

  • Novartis Investigative Site

    Amilly, 45200

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Antibes, 06600

  • Novartis Investigative Site

    Aressy, 64320

  • Novartis Investigative Site

    Avignon, 84000

  • Novartis Investigative Site

    Avignon, 84082

  • Novartis Investigative Site

    Bayeux, 14401

  • Novartis Investigative Site

    Béziers, 34525

  • Novartis Investigative Site

    Bobigny, 93009

  • Novartis Investigative Site

    Brest, 29609

  • Novartis Investigative Site

    Brest Armees, France, 29240

  • Novartis Investigative Site

    Bron, Cedex, 69677

  • Novartis Investigative Site

    Bron, 69677

  • Novartis Investigative Site

    Caen, Cedex, 14033

  • Novartis Investigative Site

    Caen, 14000

  • Novartis Investigative Site

    Caen, 14033

  • Novartis Investigative Site

    Cambrai, 59507

  • Novartis Investigative Site

    Cannes, 06414

  • Novartis Investigative Site

    Chambéry, 73011

  • Novartis Investigative Site

    Chaumont, 52014

  • Novartis Investigative Site

    Cherbourg Octeville, 50102

  • Novartis Investigative Site

    Clamart, 92140

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Compiègne, 60321

  • Novartis Investigative Site

    Contamine-sur-Arve, 74130

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Cornebarrieu, 31700

  • Novartis Investigative Site

    Dijon, 21000

  • Novartis Investigative Site

    Eaubonne, 95600

  • Novartis Investigative Site

    Honfleur, 14601

  • Novartis Investigative Site

    Hyères, 83418

  • Novartis Investigative Site

    La Roche-sur-Yon, 85295

  • Novartis Investigative Site

    La Seyne-sur-Mer, 83500

  • Novartis Investigative Site

    La Tronche, 38700

  • Novartis Investigative Site

    Lille, 59003

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Limoges

  • Novartis Investigative Site

    Lyon, 69317

  • Novartis Investigative Site

    Lyon, 69394

  • Novartis Investigative Site

    Lyon, F-69001

  • Novartis Investigative Site

    Mâcon, 71018

  • Novartis Investigative Site

    Marseille, Bouches Du Rhone, 13915

  • Novartis Investigative Site

    Marseille, 13008

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Marseille, 13915

  • Novartis Investigative Site

    Metz, F-57038

  • Novartis Investigative Site

    Metz-Tessy, 74370

  • Novartis Investigative Site

    Monaco, 98000

  • Novartis Investigative Site

    Montbéliard, 25209

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Montpellier, 34960

  • Novartis Investigative Site

    Morlaix, 29672

  • Novartis Investigative Site

    Moulins, 03006

  • Novartis Investigative Site

    Mulhouse, 68051

  • Novartis Investigative Site

    Nantes, 44093

  • Novartis Investigative Site

    Neuilly-sur-Seine, 92200

  • Novartis Investigative Site

    Nice, 06003

  • Novartis Investigative Site

    Nice, 06105

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Paris, 75475

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative Site

    Paris, 75679

  • Novartis Investigative Site

    Pau, 64046

  • Novartis Investigative Site

    Perpignan, 66000

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Poitiers, 86021

  • Novartis Investigative Site

    Pont-l'Abbé, 29123

  • Novartis Investigative Site

    Pontarlier, 25304

  • Novartis Investigative Site

    Pontoise, F-95300

  • Novartis Investigative Site

    Rennes, 35033

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Rumilly, 74150

  • Novartis Investigative Site

    Saint-Denis, France / La Reunion, 97405

  • Novartis Investigative Site

    Saint-Denis, 97400

  • Novartis Investigative Site

    Saint-Denis, 97490

  • Novartis Investigative Site

    Saint-Etienne, 42055

  • Novartis Investigative Site

    Saint-Etienne, 42100

  • Novartis Investigative Site

    Saint-Germain-en-Laye, 78105

  • Novartis Investigative Site

    Saint-Palais, 64120

  • Novartis Investigative Site

    St.-Jean, 31240

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Thonon-les-Bains, 74203

  • Novartis Investigative Site

    Toulouse, 31054

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Tours, 37044

  • Novartis Investigative Site

    Valence, 26953

  • Novartis Investigative Site

    Valenciennes, 59322

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

  • Novartis Investigative Site

    Vichy, 03201

  • Novartis Investigative Site

    Villefranche-sur-Saône, 69655

  • Novartis Investigative Site

    Wattrelos, 59393

Other trials in France

Germany67 sites

  • Novartis Investigative Site

    Ahlen, 59227

  • Novartis Investigative Site

    Augsburg, 86199

  • Novartis Investigative Site

    Bad Endbach, 35080

  • Novartis Investigative Site

    Bad Homburg, 61348

  • Novartis Investigative Site

    Bad Kreuznach, 55543

  • Novartis Investigative Site

    Bad Krozingen, 79189

  • Novartis Investigative Site

    Bad Oeynhausen, 32545

  • Novartis Investigative Site

    Berlin, 10789

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bielefeld, 33602

  • Novartis Investigative Site

    Bielefeld, 33604

  • Novartis Investigative Site

    Bonn, 53115

  • Novartis Investigative Site

    Chemnitz, 09117

  • Novartis Investigative Site

    Chemnitz, 09126

  • Novartis Investigative Site

    Chemnitz, 09130

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Cologne, 51105

  • Novartis Investigative Site

    Cologne, 51605

  • Novartis Investigative Site

    Dessau, 06847

  • Novartis Investigative Site

    Diepholz, 49356

  • Novartis Investigative Site

    Dinslaken, 46535

  • Novartis Investigative Site

    Dortmund, 44309

  • Novartis Investigative Site

    Dresden, 01067

  • Novartis Investigative Site

    Dresden, 01277

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, 40477

  • Novartis Investigative Site

    Eilenburg, D 04838

  • Novartis Investigative Site

    Eschwege, 37269

  • Novartis Investigative Site

    Essen, 45355

  • Novartis Investigative Site

    Frankfurt, 60322

  • Novartis Investigative Site

    Frankfurt, 60431

  • Novartis Investigative Site

    Frankfurt, 60439

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Friedrichroda, 99894

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Gronau, 31028

  • Novartis Investigative Site

    Günzburg, 89312

  • Novartis Investigative Site

    Hamburg, 22457

  • Novartis Investigative Site

    Hanover, 30159

  • Novartis Investigative Site

    Hanover, 30559

  • Novartis Investigative Site

    Haßfurt, 97437

  • Novartis Investigative Site

    Haßloch, 67454

  • Novartis Investigative Site

    Hohenstein-Ernstthal, 09337

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Karlsruhe, 76135

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Köthen, 06366

  • Novartis Investigative Site

    Lauchringen, 79787

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Magdeburg, 39114

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mannheim, 68167

  • Novartis Investigative Site

    Marl, 45768

  • Novartis Investigative Site

    München, 80336

  • Novartis Investigative Site

    München, 80636

  • Novartis Investigative Site

    Münster, 48153

  • Novartis Investigative Site

    Oldenburg, 26133

  • Novartis Investigative Site

    Pressath, 92690

  • Novartis Investigative Site

    Rostock, 18107

  • Novartis Investigative Site

    Süderholz, OT Bartmannshagen, 18516

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Weinheim, 69469

  • Novartis Investigative Site

    Wildeshausen, 27793

  • Novartis Investigative Site

    Wolfratshausen, 82515

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

Greece49 sites

  • Novartis Investigative Site

    Alexandroupoli, Evros, 681 00

  • Novartis Investigative Site

    Athens, GR, 115 21

  • Novartis Investigative Site

    Athens, GR, 115 25

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, GR, 14233

  • Novartis Investigative Site

    Athens, 106 76

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 115 26

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Athens, 11521

  • Novartis Investigative Site

    Athens, 11526

  • Novartis Investigative Site

    Athens, 11527

  • Novartis Investigative Site

    Athens, 145 61

  • Novartis Investigative Site

    Athens, 15127

  • Novartis Investigative Site

    Athens, 15562

  • Novartis Investigative Site

    Athens, 176 74

  • Novartis Investigative Site

    Athens, GR14564

  • Novartis Investigative Site

    Chaïdári, 12461

  • Novartis Investigative Site

    Chios, 821 00

  • Novartis Investigative Site

    Corfu, 49100

  • Novartis Investigative Site

    Edessa, 58200

  • Novartis Investigative Site

    Elefsina, 19600

  • Novartis Investigative Site

    Glyfada, 16675

  • Novartis Investigative Site

    Heraklion, 714 09

  • Novartis Investigative Site

    Heraklion - Crete, Greece, 711 10

  • Novartis Investigative Site

    Ioannina, GR, 451 10

  • Novartis Investigative Site

    Ioannina, 45001

  • Novartis Investigative Site

    Kalamata, 241 00

  • Novartis Investigative Site

    Karditsa, 43100

  • Novartis Investigative Site

    Katerini, 601 00

  • Novartis Investigative Site

    Kavala, 65 500

  • Novartis Investigative Site

    Kilkis, 611 00

  • Novartis Investigative Site

    Kozani, 50100

  • Novartis Investigative Site

    Larissa, GR, 411 10

  • Novartis Investigative Site

    Marousi, 15125

  • Novartis Investigative Site

    Piraeus, 18454

  • Novartis Investigative Site

    Piraeus, 185 36

  • Novartis Investigative Site

    Rio Patra, 26504

  • Novartis Investigative Site

    Thesaloniki, Greece, 55134

  • Novartis Investigative Site

    Thessaloniki, GR, 546 36

  • Novartis Investigative Site

    Thessaloniki, GR, 56429

  • Novartis Investigative Site

    Thessaloniki, GR, 570 10

  • Novartis Investigative Site

    Thessaloniki, 54636

  • Novartis Investigative Site

    Thessaloniki, 54642

  • Novartis Investigative Site

    Thessaloniki, 552 36

  • Novartis Investigative Site

    Tripoli, GR, 221 00

  • Novartis Investigative Site

    Volos, GR 38222

  • Novartis Investigative Site

    Voula, GR, 166 73

Other trials in Greece

Spain37 sites

  • Novartis Investigative Site

    Badajoz, Extremadura, 6011

  • Novartis Investigative Site

    Badalona, 08911

  • Novartis Investigative Site

    Baleares, Balearic Islands, 7014

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    El Palmar (Murcia), 30120

  • Novartis Investigative Site

    Galdakano, Basque Country, 48960

  • Novartis Investigative Site

    Garanada, Andalusia, 18004

  • Novartis Investigative Site

    Jerez de la Frontera, Andalusia, 11407

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, Las Palmas de G.C, 35010

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35010

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35016

  • Novartis Investigative Site

    Lleida, Catalonia, 25198

  • Novartis Investigative Site

    Logroño, La Rioja, 26006

  • Novartis Investigative Site

    Madrid, 28023

  • Novartis Investigative Site

    Madrid, 28031

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Marbella, Malaga, 29603

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Pontevedra, Galicia, 36001

  • Novartis Investigative Site

    Salamanca, 37007

  • Novartis Investigative Site

    Salt, Catalonia, 17190

  • Novartis Investigative Site

    San Sebastián de los Reyes, Madrid, 28702

  • Novartis Investigative Site

    San Sebastián de los Reyes, Madrid, 28703

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Seville, 41009

  • Novartis Investigative Site

    Seville, 41010

  • Novartis Investigative Site

    Torrelavega, Cantabria, 39300

  • Novartis Investigative Site

    Utrera, Andalusia, 41710

  • Novartis Investigative Site

    Villamartín, Cadiz, 11650

  • Novartis Investigative Site

    Zaragoza, 50009

  • Novartis Investigative Site

    Zaragoza, 50015

Other trials in Spain

Lebanon9 sites

  • Novartis Investigative Site

    Beirut, 11-2555

  • Novartis Investigative Site

    Beirut, 1107 2020

  • Novartis Investigative Site

    Beirut, 166378

  • Novartis Investigative Site

    Beirut, 5544

  • Novartis Investigative Site

    Beirut, 6301

  • Novartis Investigative Site

    Beirut

  • Novartis Investigative Site

    El Achrafiyé, 166830

  • Novartis Investigative Site

    Saida, 652

  • Novartis Investigative Site

    Tripoli

Other trials in Lebanon

Cyprus6 sites

  • Novartis Investigative Site

    Limassol, 3021

  • Novartis Investigative Site

    Nicosia, 1086

  • Novartis Investigative Site

    Nicosia, 2024

  • Novartis Investigative Site

    Nicosia, 2029

  • Novartis Investigative Site

    Nicosia, 2042

  • Novartis Investigative Site

    Nicosia, 2047

Other trials in Cyprus

Austria5 sites

  • Novartis Investigative Site

    Krems, A-3500

  • Novartis Investigative Site

    Salzburg

  • Novartis Investigative Site

    Sankt Pölten, 3100

  • Novartis Investigative Site

    Vienna, 1130

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Brazil5 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30170-040

  • Novartis Investigative Site

    Fortaleza, Ceará, 60864-190

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90620 001

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41180-780

Other trials in Brazil

Australia3 sites

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010

  • Novartis Investigative Site

    North Ryde, New South Wales, 2109

  • Novartis Investigative Site

    Perth, Western Australia, 6000

Other trials in Australia

Philippines3 sites

  • Novartis Investigative Site

    Makati City, 1229

  • Novartis Investigative Site

    Manila, National Capital Region, 1000

  • Novartis Investigative Site

    Manila, 1000

Other trials in Philippines

Ireland2 sites

  • Novartis Investigative Site

    Co Dublin, Ireland

  • Novartis Investigative Site

    Dublin, 9

Other trials in Ireland

United Arab Emirates2 sites

  • Novartis Investigative Site

    Abu Dhabi, 51900

  • Novartis Investigative Site

    Ras al-Khaimah, 4727

Other trials in United Arab Emirates

United States1 site

  • Novartis Investigative Site

    Vero Beach, Florida, 32960

Other trials in United States

Croatia1 site

  • Novartis Investigative Site

    Varaždin, HRV, 42000

Other trials in Croatia

Malta1 site

  • Novartis Investigative Site

    Msida, MSD 2090

Other trials in Malta

Panama1 site

  • Novartis Investigative Site

    Panama City

Other trials in Panama

Slovenia1 site

  • Novartis Investigative Site

    Ljubljana, 1000

Other trials in Slovenia

Switzerland1 site

  • Novartis Investigative Site

    Lucerne, Canton of Lucerne, 6004

Other trials in Switzerland

About this study

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

Being tested
LCZ696
Keywords
Multiple Patient Program, LCZ696, heart failure, heart failure with reduced ejection fraction, HF-rEF
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCZ696Drug

    immediate release film coated tablet in 50 mg, 100 mg, 200 mg, and 400 mg strengths for oral administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT02389933
Sponsor's protocol ID
CLCZ696B2318M
Status last verified
Feb 2021
First submitted
10 Mar 2015
Last updated
15 Feb 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing LCZ696 in people with Heart Failure With Reduced Ejection Fraction (HF-rEF), run by Novartis Pharmaceuticals at 286 sites in 18 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 14 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 286 sites in France, Germany, Greece, Spain, Lebanon and 13 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.

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02389933.

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 Feb 2021.

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