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 |
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).
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
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Michael Fifer
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800 Washington St
Boston, Massachusetts 02111
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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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
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
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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Bethlehem, Pennsylvania
Principal Investigator: Jamshid Shirani
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251 E Huron St
Chicago, Illinois 60611
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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6550 Fannin St
Houston, Texas 77030
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
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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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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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20 York St, N20 York St,
New Haven, Connecticut 06520
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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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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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660 S Euclid Ave
Saint Louis, Missouri 63110
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
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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