MedTrace Logo

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

NCT02678312 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2023-02-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Pediatric Heart Failure

Interventions

DRUG

LCZ696

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

DRUG

Enalapril

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

DRUG

Placebo of LCZ696

DRUG

Placebo of Enalapril

DRUG

LCZ696

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2022-01-03
Completion
2022-01-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • 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)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678312 on ClinicalTrials.gov