CLINICAL TRIALS PROFILE FOR OMECAMTIV MECARBIL

Clinical Trials for Omecamtiv Mecarbil

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00682565 ↗	PK and Tolerability of IV and Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina	Completed	Cytokinetics	Phase 2	This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy patients with angina is deleteriously affected by treatment with CK-1827452.
NCT01077167 ↗	Pharmacokinetic Study of Omecamtiv Mecarbil in Heart Failure Patients	Withdrawn	Amgen	Phase 2	The purpose of this trial is to obtain a pharmacokinetic profile (i.e. amount of drug in the blood over time) of Omecamtiv mecarbil in patients with stable heart failure.
NCT01077167 ↗	Pharmacokinetic Study of Omecamtiv Mecarbil in Heart Failure Patients	Withdrawn	Cytokinetics	Phase 2	The purpose of this trial is to obtain a pharmacokinetic profile (i.e. amount of drug in the blood over time) of Omecamtiv mecarbil in patients with stable heart failure.
NCT01300013 ↗	Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)	Completed	Cytokinetics	Phase 2	The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.
NCT01300013 ↗	Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)	Completed	Amgen	Phase 2	The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.
NCT01380223 ↗	A Pharmacokinetic and Pharmacodynamic Study of Omecamtiv Mecarbil in Healthy Volunteers	Completed	Cytokinetics	Phase 1	This study will assess the safety, tolerability, and pharmacodynamics of omecamtiv mecarbil infusion in healthy male volunteers.
NCT01786512 ↗	COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure	Completed	Cytokinetics	Phase 2	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.

Clinical Trial Conditions for Omecamtiv Mecarbil

Condition Name

Condition Name for
Intervention	Trials
Heart Failure	6
Heart Failure With Reduced Ejection Fraction	2
Healthy Volunteer	1
History of Chronic Heart Failure	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Heart Failure	10
Ventricular Dysfunction, Left	2
Systolic Murmurs	2
Angina Pectoris	1

Clinical Trial Locations for Omecamtiv Mecarbil

Trials by Country

Trials by Country for
Location	Trials
United States	113
Japan	46
Canada	21
China	17
Spain	12

Trials by US State

Trials by US State for
Location	Trials
Connecticut	4
Texas	4
South Carolina	4
Oklahoma	4
North Carolina	4

Clinical Trial Progress for Omecamtiv Mecarbil

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	5
Phase 1	3

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	8
Withdrawn	2
Active, not recruiting	1

Clinical Trial Sponsors for Omecamtiv Mecarbil

Sponsor Name

Sponsor Name for
Sponsor	Trials
Cytokinetics	15
Amgen	9
Servier	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	26