MedTrace Logo

Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure

NCT03759392 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2023-03-07

Study results available
· View outcomes & findings →

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

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

Omecamtiv Mecarbil

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

DRUG

Placebo

Oral placebo twice daily for up to 20 weeks

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Cytokinetics, MD · Cytokinetics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2021-11-08
Completion
2022-01-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03759392 on ClinicalTrials.gov