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

This study is currently recruiting participants.
Verified October 2017 by Amgen
Sponsor:
ClinicalTrials.gov Identifier:
NCT02929329
First Posted: October 11, 2016
Last Update Posted: October 20, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Cytokinetics
Servier
Information provided by (Responsible Party):
Amgen
September 30, 2016
October 11, 2016
October 20, 2017
January 6, 2017
January 27, 2021   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02929329 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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
Same as current
 
Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Heart Failure
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8000
January 27, 2021
January 27, 2021   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Argentina,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
 
 
NCT02929329
20110203
2016-002299-28 ( EudraCT Number )
Yes
Not Provided
Not Provided
Amgen
Amgen
  • Cytokinetics
  • Servier
Study Director: MD Amgen
Amgen
October 2017

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