Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

Completed · Phase 3

Conditions studied: Chronic Heart Failure With Reduced Ejection Fraction

In brief

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

Key facts

Study ID

NCT02226120

Run by

Novartis Pharmaceuticals

People needed

1980

Starts

2014-10-16

Expected to finish

2017-12-28

Last updated by the study team

2019-02-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent for the extension must be obtained before any assessment is performed.
• Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.

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 LCZ696
• Known history of angioedema
• Requirement of simultaneous 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 at Visit 1 (screening)
• Estimated GFR < 30 mL/min/1.73m\^2 as measured by the simplified MDRD formula at Visit 1 (screening)
• Presence of bilateral renal artery stenosis
• Serum potassium > 5.2 mmol/L at Visit 1 (screening)
• Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
• Pregnant or nursing (lactating) women
• Women of child-bearing potential
• Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.

Where it is running

• Novartis Investigative Site — Muscle Shoals, Alabama, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Oceanside, California, United States
• Novartis Investigative Site — Palm Springs, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Santa Rosa, California, United States
• Novartis Investigative Site — Boynton Beach, Florida, United States
• Novartis Investigative Site — Des Moines, Iowa, United States
• Novartis Investigative Site — Covington, Louisiana, United States
• Novartis Investigative Site — Columbia, Maryland, United States
• Novartis Investigative Site — Saginaw, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Fremont, Nebraska, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Rosedale, New York, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Marion, Ohio, United States
• Novartis Investigative Site — Rapid City, South Dakota, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Livingston, Texas, United States
• Novartis Investigative Site — Spokane, Washington, United States
• Novartis Investigative Site — Waukesha, Wisconsin, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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