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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:4/28/2016
Start Date:February 2013
End Date:August 2015

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A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Escalation Study to Select and Evaluate an Oral Modified Release Formulation of Omecamtiv Mecarbil in Subjects With HF and Left Ventricular Systolic Dysfunction

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 subjects
with HF and left ventricular systolic dysfunction and (ii) to characterize its
pharmacokinetics (PK) over 20 weeks of treatment.

Omecamtiv mecarbil (AMG 423, CK-1827452) is a novel small molecule that increases cardiac
contractility by selectively and directly activating the enzymatic domain of cardiac myosin
heavy chain, the force-generating motor protein of the cardiac sarcomere. This is a
randomized, placebo-controlled, multicenter, phase 2 study, consisting of a dose escalation
phase to select 1 of 3 omecamtiv mecarbil oral formulations in 2 dose escalation cohorts,
followed by an expansion phase to evaluate 20 weeks of administration of the selected
omecamtiv mecarbil formulation at 2 target dose levels, compared with placebo.

Inclusion Criteria:

- History of chronic 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 fragment BNP (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 BP > 160 mmHg or < 90 mmHg or diastolic BP > 90 mmHg

- TBL ≥ 2x ULN; AST or ALT ≥ 3x ULN

- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
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