Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
NCT ID: NCT02291237
Last Updated: 2018-09-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
172 participants
INTERVENTIONAL
2015-02-05
2017-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Eleclazine
Eleclazine 30 mg single loading dose followed by 3 mg daily maintenance dose up until Week 12, then 6 mg daily maintenance dose from Week 12 at least Week 24, followed by eleclazine 6 mg in an open-label extension period.
Eleclazine
Tablet (s) administered orally once daily
Placebo
Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.
Eleclazine
Tablet (s) administered orally once daily
Placebo
Placebo to match eleclazine administered orally once daily
Interventions
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Eleclazine
Tablet (s) administered orally once daily
Placebo
Placebo to match eleclazine administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Cedars-Sinai Heart Institute
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Athens Regional Medical Center
Athens, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Brigham & Women's Hospital and Harvard Medical School
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Columbia University Medical Center/ New York Presbyterian
New York, New York, United States
NYU School of Medicine Pediatrics
New York, New York, United States
Duke Health Center at Southpoint
Durham, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
St. Thomas Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
Texas Heart Institute
Houston, Texas, United States
UT Southwestern Medical Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Marshfield Clinic Research Institute
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Hôpital Européen Georges Pompidou
Paris, , France
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Ein Kerem-Hadassah Medical Organization
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Madonna del Soccorso Hospital
San Benedetto del Tronto, Ascoli Piceno, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Azienda Ospedaliero Universitaria Di Bologna
Bologna, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Ospedale San Raffaele S.r.l.
Milan, , Italy
Azienda Ospedaliera Monaldi
Naples, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, , Italy
Academisch Medisch Centrum Amsterdam
Amsterdam, North Holland, Netherlands
Erasmus MC
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
University Hospital of Wales
Cardiff, South Glamergon, United Kingdom
Northern General Hospital
Sheffield, Yorkshire, United Kingdom
Countries
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References
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Olivotto I, Hellawell JL, Farzaneh-Far R, Blair C, Coppini R, Myers J, Belardinelli L, Maron MS. Novel Approach Targeting the Complex Pathophysiology of Hypertrophic Cardiomyopathy: The Impact of Late Sodium Current Inhibition on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy (LIBERTY-HCM) Trial. Circ Heart Fail. 2016 Mar;9(3):e002764. doi: 10.1161/CIRCHEARTFAILURE.115.002764.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004429-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-361-1157
Identifier Type: -
Identifier Source: org_study_id
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