Study Complete
Sponsor ID
20110203

Registrational Study with Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure with Reduced Ejection FractionGALACTIC-HF

Sponsor ID
20110203
Clinicaltrials.gov ID
NCT02929329
EUCTIS ID
N/A
EudraCT ID
2016-002299-28

Study Details

The purpose of this study is to determine if treatment with omecamtiv mecarbil 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 adults with chronic heart failure with reduced ejection fraction (HFrEF).

Additional Study Details

Phase
Phase 3
Product
omecamtiv mecarbil
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
8256
Additional Study Details

Protocol Summary

Primary Outcome Measures

Measure time to cardiovascular death or first heart failure event

Timeframe: Through study completion, up to 208 weeks

Secondary Outcome Measures

Measure time to cardiovascular death

Timeframe: Through study completion, up to 208 weeks

Measure changes in patient reported outcomes Kansas City Cardiomyopathy Questionnaire Total Symptom Score

Timeframe: Week 24

Measure time to first heart failure hospitalization

Timeframe: Through study completion, up to 208 weeks

Measure time to all-cause death

Timeframe: Through study completion, up to 208 weeks

Locations

Location
Status
Contact Us
Location
Research Site
Las Vegas, NV, United States, 89118
Status
Recruiting
Location
Research Site
Tuscumbia, AL, United States, 35674
Status
Recruiting
Location
Research Site
Anaheim, CA, United States, 92801
Status
Recruiting
Location
Research Site
Ashford, SA, Australia, 5035
Status
Recruiting
Location
Research Site
Beverly Hills, CA, United States, 90211
Status
Recruiting
Location
Research Site
Carmichael, CA, United States, 95608
Status
Recruiting
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