Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction
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.
- Heart Failure
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
|Oral omecamtiv mecarbil twice daily for up to 208 weeks||
|Oral placebo twice daily for up to 208 weeks||
- NCT ID
- Active, not recruiting