Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy



Status:Terminated
Conditions:High Cholesterol, Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 65
Updated:9/26/2018
Start Date:February 5, 2015
End Date:February 17, 2017

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Study 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

The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on
exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary
exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).


Key Inclusion Criteria:

- Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a
maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis

- Exertional symptoms including at least one of the following:

- New York Heart Association (NYHA) Class ≥ II dyspnea

- Canadian Cardiovascular Society (CCS) Class ≥ II angina

- Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight

- Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)

Key Exclusion Criteria:

- Known aortic valve stenosis (moderate or severe)

- Known coronary artery disease

- Left ventricular systolic dysfunction (ejection fraction < 50%)

- Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation)
within six months prior to screening or such a procedure scheduled to occur during the
study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
27
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Timothy Wong
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Michael Fifer
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Boston, MA
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Martin Maron
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Eugene DePasquale
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Rebecca Hung
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Stephen Heitner
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: David Owens
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Athens, Georgia 30606
Principal Investigator: Kent Nilsson
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Bethlehem, Pennsylvania
Principal Investigator: Jamshid Shirani
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Sanjiv Shah
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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Durham, North Carolina 27713
Principal Investigator: Andrew Wang
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Houston, Texas 77225
Principal Investigator: Ali Marian
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Houston, Texas 77030
Principal Investigator: Aslan Turer
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Sherif Nagueh
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Ferhaan Ahmad
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Los Angeles, California 90048
Principal Investigator: Florian Rader
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1000 North Oak Avenue
Marshfield, Wisconsin 54449
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Melbourne, Victoria 3004
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Scott Cohen
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Morristown, New Jersey 07962
Principal Investigator: Martin Maron
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Nashville, Tennessee 37205
Principal Investigator: Mark Zenker
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Daniel Jacoby
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New York, New York 10027
Principal Investigator: Mathew Maurer
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New York, New York 10016
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Richard Bach
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Euan Ashley
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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