CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,572 enrolled
Drug / intervention
sacubitril/valsartan +5 moredrug
Likely dose
sacubitril/valsartan 24 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/NCT03066804
NCT03066804Phase 3Completed

A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

Novartis Pharmaceuticals·interventional·Posted Feb 28, 2017·Updated Oct 11, 2021

In Brief

A Phase 3 clinical trial evaluating sacubitril/valsartan, Enalapril, and 4 other interventions for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 2,572 participants across 380 sites in 32 countries.

Detailed Summary

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czechia, Denmark, Estonia, France, Germany, Guatemala, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Peru, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 28, 2017
Enrollment StartAug 22, 2017
Primary CompletionOct 28, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.3 years ago

Interventions

sacubitril/valsartandrug

Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

Enalaprildrug

Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

Valsartandrug

Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

Placebo to match sacubitril/valsartandrug

Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

Placebo to match enalaprildrug

Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

Placebo to match valsartandrug

Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally