CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 276 enrolled
Drug / intervention
Omecamtiv Mecarbil +1 moredrug
Likely dose
Not stated in 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/NCT03759392
NCT03759392Phase 3Completed

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance

Cytokinetics·interventional·Posted Nov 30, 2018·Updated Mar 7, 2023

In Brief

A Phase 3 clinical trial evaluating Omecamtiv Mecarbil and Placebo for Heart Failure With Reduced Ejection Fraction. Completed, enrolled 276 participants across 81 sites in 9 countries.

Detailed Summary

The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Germany, Hungary, Italy, Netherlands, Poland, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 30, 2018
Enrollment StartApr 9, 2019
Primary CompletionNov 8, 2021
Study CompletionJan 6, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.6 years ago

Interventions

Omecamtiv Mecarbildrug

Oral omecamtiv mecarbil twice daily for up to 20 weeks with dose level determined by periodic blood testing

Placebodrug

Oral placebo twice daily for up to 20 weeks