OHSU

IRB #

IRB00009861

Title

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 Heart Failure and Left Ventricular Systolic Dysfunction / Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF)

Principal Investigator

James Mudd

Study Purpose

The purpose of this study is to learn more about the safety and efficacy of a study drug (AMG423) that may increase the heart's ability to contract without increasing the need for oxygen. The investigators will also study side effects are caused by the study drug

Medical Condition(s)

Heart failure

Eligibility Criteria

Includes, but not limited to:
-Male and female subjects, 18 to 85 years old
-History of chronic heart failure
-Being treated for heart failure with a stable dose of medication(s) (such as beta blockers)

Age Range

18 - 85

Healthy Volunteers Needed

No

Duration of Participation

About 7 months

Minors Included

No

Contact

Susan Dean, RN, BSN, MPH, CCRC
Phone: (503) 494-6072

Sponsor

Amgen, Inc.

Recruitment End

01/01/2015

Compensation Provided

Yes

Compensation

Subjects will be reimbursed for study visits based on the following schedule:
Screening Visit: $50.00
Day 1: $50.00
Week 2: $125.00
Week 8: $50.00
Week 12: $125.00
Week 16: $50.00
Week 20: $50.00
Week 24: $50.00


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