Back to resultsOmecamtiv Mecarbil Post-trial Access Study
Primary Purpose
Chronic Heart Failure With Reduced Ejection Fraction
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Omecamtiv mecarbil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure With Reduced Ejection Fraction
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omecamtiv mecarbil
Arm Description
All subjects will be assigned to OM
Outcomes
Primary Outcome Measures
Number of participants administered omecamtiv mecarbil during the treatment period
Primary analysis is based on the exploratory outcome measure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04464525
Brief Title
Omecamtiv Mecarbil Post-trial Access Study
Official Title
Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
December 18, 2020 (Anticipated)
Primary Completion Date
November 27, 2026 (Anticipated)
Study Completion Date
November 27, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokinetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure With Reduced Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omecamtiv mecarbil
Arm Type
Experimental
Arm Description
All subjects will be assigned to OM
Intervention Type
Drug
Intervention Name(s)
Omecamtiv mecarbil
Other Intervention Name(s)
AMG 423
Intervention Description
Film-coated tablet administered orally.
Primary Outcome Measure Information:
Title
Number of participants administered omecamtiv mecarbil during the treatment period
Description
Primary analysis is based on the exploratory outcome measure.
Time Frame
Up to 252 weeks
Other Pre-specified Outcome Measures:
Title
Participant incidence of serious adverse events and treatment emergent adverse events
Description
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.
Time Frame
Up to 252 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Omecamtiv Mecarbil Post-trial Access Study
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