CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,980 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/NCT02226120
NCT02226120Phase 3Completed
CompareCT.gov

A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696

Novartis Pharmaceuticals·interventional·Posted Aug 27, 2014·Updated Feb 20, 2019

In Brief

A Phase 3 clinical trial evaluating LCZ696 for Chronic Heart Failure With Reduced Ejection Fraction. Completed, enrolled 1,980 participants across 394 sites in 41 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure With Reduced Ejection Fraction
CountriesArgentina, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 27, 2014
Enrollment StartOct 16, 2014
Primary CompletionDec 28, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.8 years ago

Interventions

LCZ696drug

Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid