Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pediatric Heart Failure

In brief

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

Key facts

Study ID

NCT02678312

Run by

Novartis Pharmaceuticals

People needed

393

Starts

2016-11-03

Expected to finish

2022-01-03

Last updated by the study team

2023-02-10

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Palo Alto, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Salt Lake City, Utah, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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