CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,669 enrolled
Drug / intervention
LCZ696 (sacubitril/valsartan) +5 moredrug
Likely dose
LCZ696 (sacubitril/valsartan) 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/NCT02924727
NCT02924727Phase 3Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an Acute Myocardial Infarction (AMI)

Novartis Pharmaceuticals·interventional·Posted Oct 5, 2016·Updated Jun 22, 2023

In Brief

A Phase 3 clinical trial evaluating LCZ696 (sacubitril/valsartan), Ramipril, and 4 other interventions for Acute Myocardial Infarction. Completed, enrolled 5,669 participants across 486 sites in 41 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myocardial Infarction
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 5, 2016
Enrollment StartDec 9, 2016
Primary CompletionFeb 26, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.7 years ago

Interventions

LCZ696 (sacubitril/valsartan)drug

LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively

Ramiprildrug

Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules

Placebo of LCZ696drug

Matching placebo of LCZ696 tablets

Placebo of ramiprildrug

Matching placebo of ramipril capsule

Valsartandrug

Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day to patients who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization

Placebo of valsartandrug

matching placebo of valsartan for one day to patients who will be randomized to received ramipril