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Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

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ClinicalTrials.gov Identifier: NCT02929329
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
Cytokinetics
Servier
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Omecamtiv Mecarbil Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
Actual Study Start Date : January 6, 2017
Estimated Primary Completion Date : January 27, 2021
Estimated Study Completion Date : January 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Active Treatment
Oral omecamtiv mecarbil twice daily for up to 208 weeks
Drug: Omecamtiv Mecarbil
Oral omecamtiv mecarbil twice daily for up to 208 weeks with dose level determined by periodic blood testing
Other Name: AMG 423

Placebo Comparator: Placebo
Oral placebo twice daily for up to 208 weeks
Drug: Placebo
Oral placebo twice daily for up to 208 weeks




Primary Outcome Measures :
  1. Measure time to cardiovascular death or first heart failure event [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate the effect of omecamtiv mecarbil/AMG 423 as compared with placebo in subjects with chronic heart failure with reduced ejection fraction receiving standard of care therapy


Secondary Outcome Measures :
  1. Measure time to cardiovascular death [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate effects of omecamtiv mecarbil/AMG 423 on time to cardiovascular death

  2. Measure changes in patient reported outcomes Kansas City Cardiomyopathy Questionnaire Total Symptom Score [ Time Frame: Week 24 ]
    Evaluate effect of treatment with omecamtiv mecarbil/AMG 423 on changes in patient reported outcomes

  3. Measure time to first heart failure hospitalization [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate effects of omecamtiv mecarbil/AMG 423 to first heart failure hospitalization

  4. Measure time to all-cause death [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate effects of omecamtiv mecarbil/AMG 423 to all-cause death


Other Outcome Measures:
  1. Subject incidence of reported adverse events [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate safety of omecamtiv mecarbil/AMG 423

  2. Subject incidence of reported serious adverse events of ventricular arrhythmias requiring treatment [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate safety of omecamtiv mecarbil/AMG 423

  3. Subject incidence of positively adjudicated major cardiac ischemic events [ Time Frame: Through study completion, up to 208 weeks ]
    Positively adjudicated major cardiac ischemic adverse events are: myocardial infarction, hospitalization for unstable angina, percutaneous coronary intervention/coronary artery bypass graft



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

Key Inclusion Criteria:

  • Subject has provided informed consent
  • Male or female, ≥ 18 to ≤ 85 years
  • History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days before randomization)
  • LVEF ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
  • NYHA class II to IV at most recent screening assessment.
  • Managed with HF SoC therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
  • Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
  • Elevated BNP or NT-proBNP

Other Inclusion Criteria May apply

Key Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study, or < 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
  • Subject has known sensitivity to any of the products or components to be administered during testing

Other Exclusion Criteria May apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929329


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

  Show 1009 Study Locations
Sponsors and Collaborators
Amgen
Cytokinetics
Servier
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02929329     History of Changes
Other Study ID Numbers: 20110203
2016-002299-28 ( EudraCT Number )
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
URL: https://www.amgen.com/datasharing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases