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Trial record 3 of 9 for:    omecamtiv

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02929329
First received: September 30, 2016
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Heart Failure
Drug: Omecamtiv Mecarbil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Measure time to cardiovascular death or first heart failure event [ Time Frame: Through study completion, up to 208 weeks ] [ Designated as safety issue: No ]
    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:
  • Measure time to cardiovascular death [ Time Frame: Through study completion, up to 208 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate effects of omecamtiv mecarbil/AMG 423 to all-cause death


Other Outcome Measures:
  • Subject incidence of reported adverse events [ Time Frame: Through study completion, up to 208 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Positively adjudicated major cardiac ischemic adverse events are: myocardial infarction, hospitalization for unstable angina, percutaneous coronary intervention/coronary artery bypass graft


Estimated Enrollment: 8000
Study Start Date: January 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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%, not in the setting of acute decompensation
  • NYHA class II to IV
  • 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 prior HF hospitalization, or urgent HF admission to emergency department (ED) within 1 year prior to screening
  • Elevated BNP or NT-proBNP

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)
  • Receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to randomization
  • Receiving IV inotropes or IV vasopressors ≤ 3 days prior to randomization
  • Receiving IV diuretics or IV vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to randomization
  • Acute coronary syndrome, stroke, or transient ischemic attack, major cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 3 months prior to randomization
  • Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
  • Untreated severe ventricular arrhythmia
  • Systolic BP > 140 mmHg or < 85 mmHg, or diastolic BP > 90 mmHg
  • TBL ≥ 2x ULN; AST or ALT ≥ 3x ULN
  • eGFR < 20 ml/min/1.73m2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02929329

Contacts
Contact: Amgen Call Center 866-572-6436

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02929329     History of Changes
Other Study ID Numbers: 20110203  2016-002299-28 
Study First Received: September 30, 2016
Last Updated: October 7, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016