Omecamtiv Mecarbil Post-trial Access Study

• Status: Withdrawn
• Trial end date: 2026-11-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Cytokinetics

Criteria

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.