Omecamtiv Mecarbil Post-trial Access Study

NCT04464525 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 20190370
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Number of participants administered omecamtiv mecarbil during the treatment period

  Primary analysis is based on the exploratory outcome measure.

  Up to 252 weeks

Other Outcomes (1)

• Participant incidence of serious adverse events and treatment emergent adverse events

  Up to 252 weeks

Study Arms (1)

Omecamtiv mecarbil

EXPERIMENTAL

All subjects will be assigned to OM

Drug: Omecamtiv mecarbil

Interventions

Omecamtiv mecarbil DRUG

Film-coated tablet administered orally.

Also known as: AMG 423

Omecamtiv mecarbil

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cytokinetics: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

omecamtiv mecarbil

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: December 18, 2020
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): November 27, 2026
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.