CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 393 enrolled
Drug / intervention
LCZ696 +4 moredrug
Likely dose
LCZ696 3.125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02678312
NCT02678312Phase 3Completed
CompareCT.gov

Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

Novartis Pharmaceuticals·interventional·Posted Feb 9, 2016·Updated Feb 10, 2023

In Brief

A Phase 3 clinical trial evaluating LCZ696, Enalapril, and 2 other interventions for Pediatric Heart Failure. Completed, enrolled 393 participants across 98 sites in 29 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Heart Failure
CountriesArgentina, Austria, Bulgaria, Canada, China, Croatia, Czechia, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Jordan, Lebanon, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 9, 2016
Enrollment StartNov 3, 2016
Primary CompletionJan 3, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.4 years ago

Interventions

LCZ696drug

LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules)

Enalaprildrug

Enalapril tablets: 2.5 mg, 5 mg, 10 mg dosage strengths

Placebo of LCZ696drug

Placebo of Enalaprildrug

LCZ696drug

LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), tablets: 50 mg, 100 mg, 200 mg dosage strengths