This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

Stopped early · Phase 3

Conditions studied: Heart Failure With Reduced Ejection Fraction

In brief

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =\< 35%).

Key facts

Study ID

NCT01035255

Run by

Novartis Pharmaceuticals

People needed

8442

Starts

2009-12-01

Expected to finish

2014-05-01

Last updated by the study team

2016-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must give written informed consent before any assessment is performed.
• Outpatients ≥ 18 years of age, male or female.
• Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =< 35%) and elevated BNP.
• Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks.
• Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks.

You may not qualify if…

• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
• History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
• Previous history of intolerance to recommended target doses of ACEIs or ARBs
• Known history of angioedema.
• Requirement of treatment with both ACEIs and ARBs.
• Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
• Symptomatic hypotension and/or a SBP < 100 mmHg.
• Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula
• Serum potassium > 5.2 mmol/L.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Huntsville, Alabama, United States
• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Muscle Shoals, Alabama, United States
• Novartis Investigative Site — Anchorage, Alaska, United States
• Novartis Investigative Site — Gilbert, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — Bellflower, California, United States
• Novartis Investigative Site — Berkley, California, United States
• Novartis Investigative Site — Loma Linda, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Mather, California, United States
• Novartis Investigative Site — Oceanside, California, United States
• Novartis Investigative Site — Palm Springs, California, United States
• Novartis Investigative Site — Pomona, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Santa Rosa, California, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.