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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02929329
Recruitment Status : Active, not recruiting
First Posted : October 11, 2016
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Cytokinetics
Servier
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 11, 2016
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE January 6, 2017
Estimated Primary Completion Date February 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02929329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 7, 2016)
  • Subject incidence of reported adverse events [ Time Frame: Through study completion, up to 208 weeks ]
    Evaluate safety of omecamtiv mecarbil/AMG 423
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Oral placebo twice daily for up to 208 weeks
Study Arms  ICMJE
  • Experimental: Active Treatment
    Oral omecamtiv mecarbil twice daily for up to 208 weeks
    Intervention: Drug: Omecamtiv Mecarbil
  • Placebo Comparator: Placebo
    Oral placebo twice daily for up to 208 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 16, 2019)
8258
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2016)
8000
Estimated Study Completion Date  ICMJE February 7, 2021
Estimated Primary Completion Date February 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Colombia,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02929329
Other Study ID Numbers  ICMJE 20110203
2016-002299-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE
  • Cytokinetics
  • Servier
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP