COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure

• Status: Completed
• Trial end date: 2015-08-19
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) over 20 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Cytokinetics
• Collaborator: Cytokinetics

Criteria

Inclusion Criteria:

• History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 4 weeks prior to screening

• Treated with stable, optimal pharmacological therapy for ≥ 4 weeks

• History of left ventricular ejection fraction (LVEF) ≤ 40%

• Elevated N-terminal prohormone B-type natriuretic peptide (NT-proBNP)

Exclusion criteria:

• Severe uncorrected valvular heart disease

• Hospitalization within 30 days prior to enrollment

• Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease

• Acute myocardial infarction, unstable angina or persistent angina at rest within 30 days prior to randomization

• Systolic blood pressure > 160 mmHg or < 90 mmHg or diastolic blood pressure > 90 mmHg

• Total bilirubin ≥ 2 x upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x ULN

• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2