CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 887 enrolled
Drug / intervention
sacubitril/valsartan (LCZ696) +3 moredrug
Likely dose
sacubitril/valsartan (LCZ696) 26 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/NCT02554890
NCT02554890Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Enalapril on Changes in NT-proBNP and Safety and Tolerability of In-hospital Initiation of LCZ696 Compared to Enalapril in HFrEF Patients Who Have Been Stabilized Following Hospitalization for Acute Decompensated Heart Failure (ADHF).

Novartis Pharmaceuticals·interventional·Posted Sep 18, 2015·Updated Jan 5, 2021

In Brief

A Phase 4 clinical trial evaluating sacubitril/valsartan (LCZ696), Enalapril, and 2 other interventions for Acute Heart Failure. Completed, enrolled 887 participants across 123 sites.

Detailed Summary

The purpose of this study was to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Heart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 18, 2015
Enrollment StartApr 29, 2016
Primary CompletionJun 29, 2018
Study CompletionJul 24, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.8 years ago

Interventions

sacubitril/valsartan (LCZ696)drug

sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.

Enalaprildrug

Enalapril tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.

sacubitril/valsartan (LCZ696) matching placebodrug

matching placebo of sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.

enalapril matching placebodrug

enalapril matching placebo tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.