Omecamtiv Mecarbil Post-trial Access Study

Phase 3

Withdrawn

• Conditions: Chronic Heart Failure With Reduced Ejection Fraction
• Interventions: Drug: Omecamtiv mecarbil

• Registration Number: NCT04464525
• Lead Sponsor: Cytokinetics

Brief Summary

The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.

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.

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Study Start: 2020-12-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-25
• Last Update Posted: 2021-07-30
• Primary Completion: 2026-11-27
• Study Completion: 2026-11-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participant has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures.
• Participant has completed GALACTIC-HF.

Exclusion Criteria

• Investigational product was permanently discontinued during GALACTIC-HF due to protocol-specified reason.
• Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment.
• Female participants of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with OM and for an additional 5 days after the last dose of treatment.
• Female participants of childbearing potential with a positive pregnancy test assessed on day 1 by a urine pregnancy test.
• Participant has known sensitivity to any of the products or components to be administered during dosing.
• History or evidence of any clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omecamtiv mecarbil	Omecamtiv mecarbil	All subjects will be assigned to OM

Primary Outcome Measures

Name	Time	Method
Number of participants administered omecamtiv mecarbil during the treatment period	Up to 252 weeks	Primary analysis is based on the exploratory outcome measure.