A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

NCT03066804 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CLCZ696D23022016-003410-28
• Study Type: interventional
• Target: 2,572
• Locations: 31 countries
• Sites: 377

Brief Summary

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Cardiovascular Diseases; Heart Failure; Heart failure with Preserved Ejection Fraction; NT-proBNP; 6 MWT; KCCQ; SF-36; NYHA Class; LCZ696; Enalapril; Valsartan; Angiotensin-Converting Enzyme Inhibitors (ACEi); Angiotensin II Type 1 Receptor Blockers (ARB); Renin Angiotensin System Inhibitors (RASi)

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12

  To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT-proBNP from baseline at Week 12 in patients with HFpEF

  Baseline, week 12

• Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24

  Change from baseline in 6-minute walk distance (6MWD) will be reported at Week 24. The 6 MWT will be performed in accordance with the guidelines of the American Thoracic Society 2002.

  Baseline, week 24

Secondary Outcomes (5)

• Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24

  Baseline, Week 24

• Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24

  Baseline, Week 24

• Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24

  Baseline, Week 24

• Change From Baseline in NYHA Functional Class at Week 24

  Baseline, week 24

• Change From Baseline in The Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

  Baseline, Week 24

Study Arms (2)

sacubitril/valsartan (LCZ696)

EXPERIMENTAL

All patients who fulfill the inclusion/exclusion criteria will be stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi. Patients in the ACEi strata will receive LCZ696 or enalapril. Patients in the ARB strata will receive LCZ696 or valsartan. Patients in the no RASi strata will receive LCZ696 or matching placebo. Patients in the ACEi and ARB strata will take two pills twice daily for each dose: one tablet from the LCZ696 pack and one tablet from the comparator pack. Patients in the no RASi strata will take only one tablet twice daily (LCZ696 or matching placebo). In the LCZ696 arm, patients will receive active LCZ696 in titrated doses from level 1 up to level 3 (50 mg, 100 mg and 200 mg twice daily orally).

Drug: sacubitril/valsartan; Drug: Placebo to match enalapril; Drug: Placebo to match valsartan

Comparator

ACTIVE COMPARATOR

Patients randomized to the comparator arm will receive either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum). Patients in the ACE stratum randomized to comparator, will receive enalapril in titrated doses from level 1 up to level 3 (2.5 mg, 5 mg and 10 mg twice daily). Patients in the ARB stratum randomized to comparator will receive valsartan in titrated doses from level 1 up to level 3 (40 mg , 80 mg and 160 mg twice daily). Patients in the no RASi stratum randomized to comparator will receive LCZ696 matching placebo.

Drug: Enalapril; Drug: Valsartan; Drug: Placebo to match sacubitril/valsartan

Interventions

sacubitril/valsartan DRUG

Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

sacubitril/valsartan (LCZ696)

Enalapril DRUG

Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

Comparator

Valsartan DRUG

Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

Comparator

Placebo to match sacubitril/valsartan DRUG

Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

Comparator

Placebo to match enalapril DRUG

Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

sacubitril/valsartan (LCZ696)

Placebo to match valsartan DRUG

Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally

sacubitril/valsartan (LCZ696)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular ejection fraction (LVEF) \>40% by echo within 6 months prior to study entry or during the screening epoch
• Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist \[MRAs\]) for at least 30 days prior to study entry
• NYHA class II-IV
• Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
• NT-proBNP \> 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or \>600 pg/mL for patients with AF
• KCCQ clinical summary score \< 75
• Patients on ACEi or ARB therapy must have a history of HTN

You may not qualify if:

• Any prior measurement of LVEF ≤ 40%, under stable conditions
• Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
• Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft \[CABG\]), unless an echo measurement was performed after the event confirming the LVEF to be \>40%
• Current (within 30 days from Visit 1) acute decompensated HF requiring therapy.
• Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696
• History of hypersensitivity to LCZ696 or its components
• Patients with a known history of angioedema
• Walk distance primarily limited by non-cardiac comorbid conditions at study entry
• Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \<10 g/dL males and \< 9.5 g/dL females, or body mass index (BMI) \> 40 kg/m\^2.
• Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP \>150 mmHg and \<180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP \< 110 mmHg at study entry.
• Patients with HbA1c \> 7.5% not treated for diabetes
• Patients with prior major organ transplant or intent to transplant (ie on transplant list)
• eGFR \< 30 ml/min/1.73 m\^2 as measured by MDRD at screening
• Serum potassium \> 5.2 mmol /L (or equivalent plasma potassium value) at study entry
• History or presence of any other disease with a life expectancy of \< 3 years

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (380)

Novartis Investigative Site

Andalusia, Alabama, 36420, United States

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Mobile, Alabama, 36608, United States

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Beverly Hills, California, 90211, United States

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Long Beach, California, 90813, United States

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Santa Ana, California, 92704, United States

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Sylmar, California, 91342, United States

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Aurora, Colorado, 80045, United States

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Stamford, Connecticut, 06905, United States

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Bradenton, Florida, 34209, United States

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Gainesville, Florida, 32608, United States

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Hollywood, Florida, 33312, United States

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Miami, Florida, 33133, United States

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Port Orange, Florida, 32127, United States

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Thomasville, Georgia, 31792, United States

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Arlington Heights, Illinois, 60004, United States

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Alexandria, Louisiana, 71301, United States

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Chalmette, Louisiana, 70043, United States

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Houma, Louisiana, 70360, United States

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Boston, Massachusetts, 02114, United States

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Lincoln, Nebraska, 68526, United States

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Omaha, Nebraska, 68114, United States

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Rochester, New York, 14621, United States

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Marion, Ohio, 43302, United States

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Corvallis, Oregon, 97330, United States

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Abington, Pennsylvania, 19001, United States

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Sioux Falls, South Dakota, 57104, United States

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Jackson, Tennessee, 38301, United States

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Dallas, Texas, 75234, United States

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Lufkin, Texas, 75904, United States

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Tomball, Texas, 77375, United States

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Falls Church, Virginia, 22042, United States

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Seattle, Washington, 98122, United States

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Caba, Buenos Aires, C1280AEB, Argentina

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Quilmes, Buenos Aires, B1878GEG, Argentina

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Posadas, Misiones Province, N3300AHX, Argentina

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Salta, Salta Province, A4406BPF, Argentina

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San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL, Argentina

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Rosario, Santa Fe Province, S2000DSV, Argentina

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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

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Buenos Aires, C1430EGF, Argentina

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Córdoba, X5000AAW, Argentina

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Córdoba, X5000EVQ, Argentina

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Córdoba, X5000, Argentina

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Córdoba, X5004BAL, Argentina

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Córdoba, X5006CBI, Argentina

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Formosa, P3600, Argentina

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San Luis, D5702JRS, Argentina

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Santa Fe, 3080, Argentina

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Santa Fe, S2200, Argentina

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Santa Fe, S3000FWO, Argentina

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Braunau am Inn, A5280, Austria

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Graz, A-8036, Austria

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Hall in Tirol, 6060, Austria

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Linz, 4010, Austria

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Salzburg, 5020, Austria

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Heusden-Zolder, 3550, Belgium

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Huy, 4500, Belgium

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Kortrijk, 8500, Belgium

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Fortaleza, Ceará, 60430 370, Brazil

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Goiânia, Goiás, 74223-130, Brazil

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Goiânia, Goiás, 74605 050, Brazil

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Belo Horizonte, Minas Gerais, 30140 062, Brazil

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Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Curitiba, Paraná, 80230 130, Brazil

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Canoas, Rio Grande do Sul, 92425 900, Brazil

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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

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Blumenau, Santa Catarina, 89010 500, Brazil

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Campinas, São Paulo, 13060 080, Brazil

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Ribeirão Preto, São Paulo, 14048-900, Brazil

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São José do Rio Preto, São Paulo, 15015-750, Brazil

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São José do Rio Preto, São Paulo, 15090-000, Brazil

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Burgas, 8018, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Pernik, 2300, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Plovdiv, 4002, Bulgaria

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Shumen, 9700, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1527, Bulgaria

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Sofia, 1606, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Moncton, New Brunswick, E1G 1A7, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Oakville, Ontario, L6K 3W7, Canada

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Montreal, Quebec, H1T 1C8, Canada

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St-Georges Beauce, Quebec, G5Y 4T8, Canada

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Medellín, Antioquia, 050036, Colombia

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Cali, Valle del Cauca Department, 760001, Colombia

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Barranquilla, 080020, Colombia

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Barranquilla, Colombia

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Montería, Colombia

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San Gil, 684031, Colombia

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Brandýs nad Labem, Czech Republic, 250 01, Czechia

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Brno, Czech Republic, 60200, Czechia

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Český Krumlov, Czech Republic, 381 01, Czechia

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Jablonec nad Nisou, Czech Republic, 466 60, Czechia

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Kroměříž, Czech Republic, 767 55, Czechia

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Liberec, Czech Republic, 46063, Czechia

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Louny, Czech Republic, Czechia

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Pardubice, Czech Republic, 532 03, Czechia

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Pilsen, Czech Republic, 30100, Czechia

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Svitavy, Czech Republic, 568 25, Czechia

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Tábor, Czech Republic, 39003, Czechia

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Třebíč, Czech Republic, 674 01, Czechia

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Jihlava, CZE, 58633, Czechia

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Policska, CZE, 57201, Czechia

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Kolín, 280 20, Czechia

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Olomouc Lazce, 77900, Czechia

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Přerov, 751 52, Czechia

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Valašské Meziříčí, 75742, Czechia

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Copenhagen NV, DK-2400, Denmark

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Hvidovre, 2650, Denmark

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Randers, 8930, Denmark

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Tallinn, 10138, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Besançon, 25030, France

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Chambray-lès-Tours, 37170, France

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Corbeil-Essonnes, 91100, France

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Le Coudray, 28630, France

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Le Kremlin-Bicêtre, 94275, France

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Limoges, 87042, France

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Marseille, 13008, France

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Rennes, 35033, France

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Tourcoing, 59200, France

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Valenciennes, 59300, France

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Regensburg, Bavaria, 93053, Germany

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Essen, DEU, 45138, Germany

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Detmold, North Rhine-Westphalia, 32756, Germany

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Dresden, Saxony, 01099, Germany

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Bad Homburg, 61348, Germany

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Bad Oeynhausen, 32545, Germany

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Bamberg, 96049, Germany

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Berlin, 10787, Germany

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Berlin, 10789, Germany

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Berlin, 12157, Germany

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Berlin, 12683, Germany

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Berlin, 13347, Germany

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Berlin, 13353, Germany

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Berlin, D 10559, Germany

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Bielefeld, 33604, Germany

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Brüel, 19412, Germany

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Buch, 13125, Germany

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Chemnitz, 09130, Germany

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Coburg, 96450, Germany

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Cologne, D-51065, Germany

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Dortmund, 44137, Germany

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Dortmund, 44379, Germany

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Dresden, 01069, Germany

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Dresden, 01277, Germany

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Dresden, 01307, Germany

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Elsterwerda, 04910, Germany

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Erfurt, 99097, Germany

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Essen, 45277, Germany

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Frankfurt, 60594, Germany

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Frankfurt, 65929, Germany

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Fulda, 36037, Germany

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Fürth, 90766, Germany

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Halle, 06120, Germany

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Hamburg, 21075, Germany

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Haßloch, 67454, Germany

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Jena, 07740, Germany

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Kiel, 24105, Germany

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Koeln-Nippes, 50733, Germany

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Leipzig, 04103, Germany

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Ludwigshafen, 67067, Germany

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Ludwigshafen, 67071, Germany

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Lübeck, 23538, Germany

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Lüneburg, 21339, Germany

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Mainz, 55116, Germany

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Mannheim, 68165, Germany

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Munich, 80638, Germany

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Mühldorf, 84453, Germany

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Münster, 48149, Germany

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Neuruppin, 16816, Germany

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Nienburg, 31582, Germany

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Nuremberg, 90402, Germany

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Papenburg, 26871, Germany

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Potsdam, 14471, Germany

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Riesa, 01589, Germany

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Rodgau, 63110, Germany

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Rostock, 18107, Germany

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Rotenburg an der Fulda, 36199, Germany

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Rüsselsheim am Main, 65428, Germany

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Schwäbisch Hall, 74523, Germany

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Siegen, 57072, Germany

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Stadtlohn, 48703, Germany

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Ulm, 89077, Germany

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Ulm, 89081, Germany

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Wallerfing, 94574, Germany

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Wattenscheid, 44866, Germany

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Wedel, 22880, Germany

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Wismar, 23966, Germany

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Würzburg, 97080, Germany

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Guatemala City, 01001, Guatemala

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Guatemala City, 01010, Guatemala

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Guatemala City, 01011, Guatemala

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Guatemala City, 01015, Guatemala

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Budapest, HUN, 1145, Hungary

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Budapest, 1085, Hungary

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Budapest, 1134, Hungary

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Mosanmagyarovar, 9200, Hungary

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Szeged, 6720, Hungary

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Ahmedabad, Gujarat, 380 060, India

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Vadodara, Gujarat, 390022, India

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Manipal, Karnataka, 576104, India

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Nagpur, Maharashtra, 440009, India

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Nashik, Maharashtra, 422005, India

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Nashik, Maharashtra, 422007, India

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New Delhi, National Capital Territory of Delhi, 110 060, India

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New Delhi, National Capital Territory of Delhi, 110007, India

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Bikaner, Rajasthan, 334003, India

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Lucknow, Uttar Pradesh, 226003, India

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India, 560040, India

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Ashkelon, 78278, Israel

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Beersheba, 84101, Israel

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Hadera, Israel

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Haifa, 310 9601, Israel

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Petah Tikva, 4941492, Israel

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Rehovot, 76100, Israel

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Cortona, AR, 52044, Italy

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Bergamo, BG, 24127, Italy

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Bologna, BO, 40138, Italy

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Legnano, MI, 20025, Italy

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Milan, MI, 20132, Italy

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Milan, MI, 20162, Italy

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Sesto San Giovanni, MI, 20099, Italy

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Palermo, PA, 90127, Italy

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Rovigo, RO, 45100, Italy

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Sassari, SS, 07100, Italy

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Cona, Italy

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San Vito al Tagliamento, Italy

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Liepāja, LVA, 3401, Latvia

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Daugavpils, LV-5417, Latvia

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Ogre, 5001, Latvia

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Riga, 1012, Latvia

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Kaunas, LTU, LT 50161, Lithuania

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Kaunas, 47144, Lithuania

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Vilnius, LT-08661, Lithuania

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Guadalajara, Jalisco, 44200, Mexico

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Guadalajara, Jalisco, 44670, Mexico

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Querétaro, 76000, Mexico

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San Luis Potosí City, 78200, Mexico

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Almelo, 7609 PP, Netherlands

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Amsterdam, 1091AC, Netherlands

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Deventer, 7416 SE, Netherlands

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Doetinchem, 7009 BL, Netherlands

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Gouda, 2803 HH, Netherlands

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Groningen, 9713 GZ, Netherlands

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Hardenberg, 7770 AA, Netherlands

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Nijmegen, 6500 HB, Netherlands

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Stadskanaal, 9501 HE, Netherlands

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Tilburg, 5022 GC, Netherlands

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Venlo, 5912 BL, Netherlands

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Trujillo, La Libertad, Peru

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Jesus Maria, Lima region, 11, Peru

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Lima Cercado, Lima region, 01, Peru

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San Borja, Lima region, 41, Peru

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San Isidro, Lima region, 27, Peru

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San Miguel, Lima region, 32, Peru

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Callao, CALLAO 2, Peru

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Braga, 4710243, Portugal

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Lisbon, 1495 005, Portugal

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Novartis Investigative Site

Lisbon, 1500 650, Portugal

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Novartis Investigative Site

Lisbon, 1600190, Portugal

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Novartis Investigative Site

Penafiel, 4564-007, Portugal

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Novartis Investigative Site

Porto, 4099-001, Portugal

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Novartis Investigative Site

Viana do Castelo, 4901858, Portugal

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Novartis Investigative Site

Vila Real, 5000-508, Portugal

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Novartis Investigative Site

Bucharest, District 4, 4204179, Romania

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Novartis Investigative Site

Timișoara, Timiș County, 300041, Romania

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Novartis Investigative Site

Timișoara, Timiș County, 300362, Romania

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Novartis Investigative Site

Bacau, 600114, Romania

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Novartis Investigative Site

Baia Mare, 430123, Romania

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Novartis Investigative Site

Bucharest, 021659, Romania

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Novartis Investigative Site

Bucharest, 022328, Romania

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Novartis Investigative Site

Bucharest, 062272, Romania

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Novartis Investigative Site

Craiova, 200642, Romania

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Novartis Investigative Site

Craiova, 200931, Romania

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Novartis Investigative Site

Piteşti, 110084, Romania

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Novartis Investigative Site

Târgovişte, 130095, Romania

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Novartis Investigative Site

Târgu Mureş, 540142, Romania

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Novartis Investigative Site

Târgu Mureş, 540143, Romania

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Novartis Investigative Site

Timișoara, 300736, Romania

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Novartis Investigative Site

Gatchina, 188300, Russia

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Novartis Investigative Site

Ivanovo, 153012, Russia

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Novartis Investigative Site

Moscow, 101953, Russia

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Novartis Investigative Site

Moscow, 117292, Russia

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Novartis Investigative Site

Moscow, 117556, Russia

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Novartis Investigative Site

Moscow, 121309, Russia

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Novartis Investigative Site

Moscow, 129301, Russia

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Novartis Investigative Site

Nizhny Novgorod, 603126, Russia

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Perm, 614097, Russia

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Novartis Investigative Site

Rostov-on-Don, 344022, Russia

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Novartis Investigative Site

Rostov-on-Don, 344068, Russia

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Novartis Investigative Site

Saint Petersburg, 191015, Russia

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Novartis Investigative Site

Saint Petersburg, 191144, Russia

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Novartis Investigative Site

Saint Petersburg, 196601, Russia

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Novartis Investigative Site

Saint Petersburg, 197376, Russia

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Novartis Investigative Site

Saint Petersburg, 199106, Russia

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Saratov, 410012, Russia

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Tyumen, 625026, Russia

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Yaroslavl, 150047, Russia

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Yekaterinburg, 620028, Russia

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Novartis Investigative Site

Yekaterinburg, 620109, Russia

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Belgrade, 11 000, Serbia

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Kamenitz, 21204, Serbia

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Kragujevac, 34000, Serbia

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Niš, 18000, Serbia

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Niška Banja, 18205, Serbia

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Novartis Investigative Site

Námestovo, Slovak Republic, 02901, Slovakia

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Novartis Investigative Site

Prešov, Slovak Republic, 080 01, Slovakia

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Novartis Investigative Site

Bratislava, SVK, 81108, Slovakia

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Novartis Investigative Site

Handlová, SVK, 97251, Slovakia

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Novartis Investigative Site

Bardejov, 085 01, Slovakia

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Novartis Investigative Site

Bardejov, 08501, Slovakia

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Novartis Investigative Site

Bratislava, 821 07, Slovakia

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Novartis Investigative Site

Bratislava, 842 31, Slovakia

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Dolný Kubín, 026 01, Slovakia

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Košice, 040 01, Slovakia

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Lučenec, 98439, Slovakia

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Moldava nad Bodvou, 045 01, Slovakia

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Nitra, 949 01, Slovakia

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Nové Zámky, 940 01, Slovakia

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Novartis Investigative Site

Nové Zámky, 94002, Slovakia

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Považská Bystrica, 01701, Slovakia

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Novartis Investigative Site

Prešov, 08001, Slovakia

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Snina, 09601, Slovakia

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Svidník, 089 01, Slovakia

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Trnava, 91701, Slovakia

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Córdoba, Andalusia, 14004, Spain

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Huelva, Andalusia, 21005, Spain

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Málaga, Andalusia, 29010, Spain

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Puerto Real, Cadiz, 11510, Spain

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Villamartín, Cadiz, 11650, Spain

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Lleida, Catalonia, 25198, Spain

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A Coruña, Galicia, 15006, Spain

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San Sebastián de los Reyes, Madrid, 28702, Spain

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El Palmar, Murcia, 30120, Spain

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Manises, Valencia, 46940, Spain

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Torrevieja (Alicante), Valencia, 03186, Spain

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Valencia, Valencia, 46010, Spain

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Alicante, 03700, Spain

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Las Palmas de Gran Canarias, 35010, Spain

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Novartis Investigative Site

Madrid, 28040, Spain

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Seville, 41014, Spain

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Valencia, 46026, Spain

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Muang, Muang, 65000, Thailand

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Khon Kaen, THA, 40002, Thailand

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Ubon Ratchathani, 34000, Thailand

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Novartis Investigative Site

Eskişehir, Meselik, 26480, Turkey (Türkiye)

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Adana, 01160, Turkey (Türkiye)

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Ankara, 06490, Turkey (Türkiye)

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Antalya, 07070, Turkey (Türkiye)

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Aydin, 09100, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Istanbul, 34304, Turkey (Türkiye)

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Novartis Investigative Site

Istanbul, 34662, Turkey (Türkiye)

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Izmir, 35040, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, 35340, Turkey (Türkiye)

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Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

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Novartis Investigative Site

Mersin, 33343, Turkey (Türkiye)

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Sivas, 58140, Turkey (Türkiye)

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Talas / Kayseri, 38039, Turkey (Türkiye)

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Novartis Investigative Site

High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom

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Novartis Investigative Site

Stockton-on-Tees, Cleveland, TS19 8PE, United Kingdom

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Novartis Investigative Site

Chesterfield, Derbyshire, S44 5BL, United Kingdom

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Craigavon, Northern Ireland, BT63 5QQ, United Kingdom

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Wansford, Peterborough, PE8 6PL, United Kingdom

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Addlestone, Surrey, KT15 2BH, United Kingdom

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Sunderland, Tyne and Wear, SR4 7TP, United Kingdom

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Leeds, LS1 3EX, United Kingdom

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York, YO31 8HE, United Kingdom

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Related Publications (1)

• Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

  PMID: 34783839 DERIVED

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination; Enalapril; Valsartan

Condition Hierarchy (Ancestors)

Heart Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Essential

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: August 22, 2017
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: October 11, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (5); DK (3); FR (10); TU (14); ES (17); DE (68); TH (6); IN (11); BU (12); GB (9); PE (7); IT (12); RU (21); SE (5); RO (15); NL (11); LA (4); AR (18); HU (5); CA (5); US (32); BR (13); CZ (18); LI (3); IL (6); CO (6); GU (4); SL (20); AU (5); ME (4); PT (8)