CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 465 enrolled
Drug / intervention
LCZ696 (sacubitril/valsartan) +3 moredrug
Likely dose
LCZ696 (sacubitril/valsartan) 26mgfrom 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/NCT02874794
NCT02874794Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Active-controlled, Forced-titration, 12-week Comparison of Combined Angiotensin-neprilysin Inhibition With Sacubitril and Valsartan Versus Enalapril on Changes in Central Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF)

Novartis Pharmaceuticals·interventional·Posted Aug 22, 2016·Updated Jan 5, 2021

In Brief

A Phase 4 clinical trial evaluating LCZ696 (sacubitril/valsartan), Enalapril, and 2 other interventions for Heart Failure and Reduced Ejection Fraction. Completed, enrolled 465 participants across 81 sites.

Detailed Summary

To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction \[LVEF\] ≤ 40%) after 12 weeks of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ in early systole) between baseline and Week 12.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure and Reduced Ejection Fraction
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 22, 2016
Enrollment StartAug 17, 2016
Primary CompletionDec 13, 2018
Study CompletionJan 26, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.9 years ago

Interventions

LCZ696 (sacubitril/valsartan)drug

24/26mg, 49/51mg and 97/103mg oral, tablets.

Enalaprildrug

2.5mg, 5mg, and 10mg, oral, tablets

Placebo of Enalaprildrug

matching placebo (2.5mg, 5mg and 10mg) oral, tablets

Placebo of LCZ696drug

matching placebo (24/26mg, 49/51mg and 97/103mg) oral, tablets