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

• Status: Completed
• Trial end date: 2020-09-14
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Cytokinetics
• Collaborators: Cytokinetics; Servier

Criteria

Key Inclusion Criteria:

• Subject has provided informed consent

• Male or female, ≥ 18 to ≤ 85 years

• History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization

• Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.

• New York Heart Association (NYHA) class II to IV at most recent screening assessment.

• Managed with HF standard of care (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 B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (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