At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 1,002 enrolled

Drug / intervention

LCZ696drug

Likely dose

LCZ696 200 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/NCT02661217

NCT02661217Phase 4Completed

Compare CT.gov

A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)

Novartis Pharmaceuticals·interventional·Posted Jan 22, 2016·Updated Apr 26, 2021

In Brief

A Phase 4 clinical trial evaluating LCZ696 for Heart Failure With Reduced Ejection Fraction. Completed, enrolled 1,002 participants across 152 sites in 19 countries.

Detailed Summary

To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHeart Failure With Reduced Ejection Fraction

CountriesArgentina, Belgium, Canada, Czechia, France, Germany, Italy, Lebanon, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Collaborators--

Timeline

Phase 4CompletedFinished

20162017201820192020202120222023202420252026

First PostedJan 2016

Enrollment StartFeb 2016

Primary CompletionFeb 2018

Study CompletionJun 2018

TodayJul 2026

First PostedJan 22, 2016

Enrollment StartFeb 12, 2016

Primary CompletionFeb 20, 2018

Study CompletionJun 20, 2018

TodayJul 2, 2026

Enrollment to primary: 2.0 yearsPosted 10.4 years ago

Interventions

LCZ696drug

LCZ696 film-coated tables were supplied to the investigators. Tablets were taken with a glass of water, and were administered with or without food. The target dose of LCZ696 was 200 mg twice daily. Starting dose of LCZ696 was either 50 or 100 mg, twice daily. The dose of LCZ696 should be doubled every 2-4 weeks to achieve the target dose of 200 mg twice daily, as tolerated by the patient.