NCT02695420

Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

* To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart failure (HF) with reduced ejection fraction * To evaluate the safety and tolerability of oral omecamtiv mecarbil

Detailed description

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DRUG	25 mg Omecamtiv Mecarbil	oral tablet
DRUG	Placebo	oral tablet
DRUG	37.5 mg Omecamtiv Mecarbil	oral tablet
DRUG	50 mg Omecamtiv Mecarbil	oral tablet

Timeline

• Start date: 2016-04-14
• Primary completion: 2017-04-06
• Completion: 2017-05-08
• First posted: 2016-03-01
• Last updated: 2021-07-27
• Results posted: 2020-01-31

Locations

32 sites across 1 country: Japan