IRB #

IRB00010645

Title

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (GS-US-361-1157)

Principal Investigator

Stephen Heitner

Study Purpose

The purpose of this study is to learn more about how to treat symptomatic hypertrophic cardiomyopathy (HCM). HCM is a disease that makes the heart muscle abnormally thick for no clear reason. This thick heart muscle can make it harder for blood to flow through the heart, forcing the heart to work extra hard to pump blood. HCM can cause symptoms like shortness of breath and chest pain.

Medical Condition(s)

Hypertrophic Cardiomyopathy (HCM)
Cardiovascular

Eligibility Criteria

Includes but not limited to:
Male or female age 18-65
Diagnosed HCM
Ability to walk upright on a treadmill

Age Range

18 - 70

Healthy Volunteers Needed

No

Duration of Participation

This study will last about 24 weeks. After 24 weeks, subjects may be invited to participate in an extension period (taking only active study drug). The extension period will continue indefinitely and a study visit will be done every 6 months.

Minors Included

No

Contact

Cardiovascular Research
503 418-1964

Sponsor

Gilead Sciences, Inc.

Recruitment End

04/28/2017

Compensation Provided

Yes

Compensation

Subjects will receive $50.00 for each of the study visits completed in Part 1 of the study, including the screening visit. If subjects continue in the open-label extension (Part 2 of the study), they will be paid $50.00 for each study visit completed in the clinic. This money is meant to assist in paying any travel expenses, lost wages from work, child care, etc. that subjects may have as a result of taking part in this study. Subjects may also receive reimbursement for any unscheduled visit(s).

Subjects who live a long distance from OHSU may be reimbursed for reasonable larger travel expenses (for example, airfare, train fare, overnight lodging) based on the actual cost of the travel expense, or the study site might arrange this travel.


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