Omecamtiv Mecarbil Post-trial Access Study

• ClinicalTrials.gov Identifier: NCT04464525
• Recruitment Status: Withdrawn
• First Posted: July 9, 2020
• Last Update Posted: December 24, 2020
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chronic Heart Failure With Reduced Ejection Fraction	Drug: Omecamtiv mecarbil	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF
• Estimated Study Start Date: December 18, 2020
• Estimated Primary Completion Date: November 27, 2026
• Estimated Study Completion Date: November 27, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Omecamtiv mecarbil; All subjects will be assigned to OM	Drug: Omecamtiv mecarbil; Film-coated tablet administered orally.; Other Name: AMG 423

Outcome Measures

Primary Outcome Measures :

1. Number of participants administered omecamtiv mecarbil during the treatment period [ Time Frame: Up to 252 weeks ]
   Primary analysis is based on the exploratory outcome measure.

Other Outcome Measures:

1. Participant incidence of serious adverse events and treatment emergent adverse events [ Time Frame: Up to 252 weeks ]
   Targeted adverse events are those which lead to temporary or permanent discontinuation of OM, adverse events that are possibly related to OM or study procedures, and all adverse events of myocardial infarction, myorcardial ischemia, and ventricular arrhythmia, irrespective of seriousness and relationship to OM.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT04464525
• Other Study ID Numbers: 20190370
• First Posted: July 9, 2020
• Last Update Posted: December 24, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.
• URL: https://www.amgen.com/datasharing

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases