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

Last updated: August 24, 2018
Sponsor: Gilead Sciences
Overall Status: Terminated

Phase

2/3

Condition

Cardiomyopathy

Heart Disease

Circulation Disorders

Treatment

Eleclazine

Placebo

Clinical Study ID

NCT02291237
GS-US-361-1157
2013-004429-97
  • Ages 18-65
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as amaximal 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)

Exclusion

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 thestudy Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 172
Treatment Group(s): 2
Primary Treatment: Eleclazine
Phase: 2/3
Study Start date:
February 05, 2015
Estimated Completion Date:
February 17, 2017

Connect with a study center

  • Royal Brisbane & Women's Hospital

    Herston, Queensland
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria
    Australia

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris,
    France

    Site Not Available

  • Universität Heidelberg, Universitätsklinikum Mannheim

    Mannheim, Baden-Württemberg
    Germany

    Site Not Available

  • Klinikum der Universität Regensburg

    Regensburg, Bayern
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • Ein Kerem-Hadassah Medical Organization

    Jerusalem,
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva,
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat-Gan,
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    Site Not Available

  • Madonna del Soccorso Hospital

    San Benedetto del Tronto, Ascoli Piceno
    Italy

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Di Bologna

    Bologna,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence,
    Italy

    Site Not Available

  • Ospedale San Raffaele S.r.l.

    Milan,
    Italy

    Site Not Available

  • Azienda Ospedaliera Monaldi

    Naples,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria di Parma

    Parma,
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini

    Rome,
    Italy

    Site Not Available

  • Academisch Medisch Centrum Amsterdam

    Amsterdam, Noord-Holland
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam,
    Netherlands

    Site Not Available

  • University Medical Center Utrecht

    Utrecht,
    Netherlands

    Site Not Available

  • University Hospital of Wales

    Cardiff, South Glamergon
    United Kingdom

    Site Not Available

  • Northern General Hospital

    Sheffield, Yorkshire
    United Kingdom

    Site Not Available

  • Cardiac Department, Queen Elizabeth Hospital Birmingham

    Birmingham,
    United Kingdom

    Site Not Available

  • University College London

    London,
    United Kingdom

    Site Not Available

  • Mayo Clinic Arizona

    Scottsdale, Arizona
    United States

    Site Not Available

  • Cedars-Sinai Heart Institute

    Los Angeles, California
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California
    United States

    Site Not Available

  • Stanford University

    Stanford, California
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut
    United States

    Site Not Available

  • Athens Regional Medical Center

    Athens, Georgia
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois
    United States

    Site Not Available

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland
    United States

    Site Not Available

  • Brigham & Women's Hospital and Harvard Medical School

    Boston, Massachusetts
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York
    United States

    Site Not Available

  • Columbia University Medical Center/ New York Presbyterian

    New York, New York
    United States

    Site Not Available

  • NYU School of Medicine Pediatrics

    New York, New York
    United States

    Site Not Available

  • Duke Health Center at Southpoint

    Durham, North Carolina
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon
    United States

    Site Not Available

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • St. Thomas Research Institute

    Nashville, Tennessee
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas
    United States

    Site Not Available

  • Texas Heart Institute

    Houston, Texas
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Houston, Texas
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington
    United States

    Site Not Available

  • Marshfield Clinic Research Institute

    Marshfield, Wisconsin
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin
    United States

    Site Not Available

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