NCT03759392

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed description

Oversight Authorities: United States: Food and Drug Administration Canada: Health Canada France: National Agency for the Safety of Medicine and Health Products Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy and Nutrition Italy: Italian Medicines Agency Netherlands: Medicines Evaluation Board Poland: Chief Pharmaceutical Inspectorate Sweden: Medical Products Agency

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-09
• Primary completion: 2021-11-08
• Completion: 2022-01-06
• First posted: 2018-11-30
• Last updated: 2023-03-07
• Results posted: 2023-03-07

Locations

81 sites across 9 countries: United States, Canada, France, Germany, Hungary, Italy, Netherlands, Poland, Sweden

Regulatory

• FDA-regulated drug study