Study of Ambrisentan in Participants With Pulmonary Hypertension

Last updated: September 8, 2020
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

Pulmonary Arterial Hypertension

Lung Injury

Treatment

N/A

Clinical Study ID

NCT00777920
GS-US-300-0124
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. The available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. Investigators will be able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose adjustments is required. Participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. Participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Men and women with pulmonary hypertension who are discontinuing a clinical study ofambrisentan due to study closure by the sponsor. Eligible participants are thoseparticipating in countries where ambrisentan is not yet commercially available.Participants participating in countries where ambrisentan is commercially availablemay be eligible if they do not qualify for treatment per the current prescribinginformation of that country.

Exclusion

Key Exclusion Criteria:

  • Participants who have discontinued an ambrisentan clinical study for any other reasonthan sponsor-initiated study closure are not eligible. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 140
Study Start date:
November 17, 2008
Estimated Completion Date:
September 11, 2019

Connect with a study center

  • Clinica Independencia Munro

    Buenos Aires, 1605
    Argentina

    Site Not Available

  • Hospital Británico de Buenos Aires

    Buenos Aires, C1280AEB
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Mar del Plata

    Buenos Aires, B7600FZN
    Argentina

    Site Not Available

  • Sanatorio Otamendi y Miroli

    Buenos Aires, C1115AAb
    Argentina

    Site Not Available

  • UAI Hospital Universitario

    Buenos Aires, C1437BZL
    Argentina

    Site Not Available

  • Fundación Rusculleda

    Cordoba, X5003DCE
    Argentina

    Site Not Available

  • Hospital Privado Centro Medico de Cordoba S.A.

    Cordoba, X5016KEH
    Argentina

    Site Not Available

  • Instituto de Cardiologia Hospital Italiano de Cordoba

    Cordoba, X5004FJE
    Argentina

    Site Not Available

  • Instituto de Cardiologia J.F. Cabral

    Corrientes, W3400AMZ
    Argentina

    Site Not Available

  • Hospital Italiano

    Rosario, S2001ODA
    Argentina

    Site Not Available

  • St. Vincent's Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME

    Belo Horizonte, 30380-090
    Brazil

    Site Not Available

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 92020-090
    Brazil

    Site Not Available

  • UBEA, Hospital Sao Lucas de Pontifícia

    Porto Alegre, 90610 000
    Brazil

    Site Not Available

  • Hospital Universitario Clementino Fraga Filho

    Rio de Janeiro, 21949-900
    Brazil

    Site Not Available

  • Hospital das Clinicas da FMUSP

    Sao Paulo, CEP05403-000
    Brazil

    Site Not Available

  • Universidade do Estado de Sao Paulo - UNIFESP

    Sao Paulo, 4023-062
    Brazil

    Site Not Available

  • Peter Lougheed Centre

    Calgary, Alberta T1Y 6J4
    Canada

    Site Not Available

  • University of Alberta Hospitals

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Centro de Estudios Cardiologicos Santiago Oriente

    Santiago, 7500503
    Chile

    Site Not Available

  • Hospital Clinico de la Pontificia Universidad Catolica de Chile

    Santiago, 8330074
    Chile

    Site Not Available

  • Instituto Nacional del Torax

    Santiago, 7500691
    Chile

    Site Not Available

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Delegacion Tlalpan Distrito Federal, 14080
    Mexico

    Site Not Available

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Mexico City, 14080
    Mexico

    Site Not Available

  • Unidad de Investigacion Clinica en Medicina S.C.

    Monterrey, 64718
    Mexico

    Site Not Available

  • Russian Cardiology Research Complex

    Moscow, 121552
    Russian Federation

    Site Not Available

  • State Medico Stomatologic University

    Moscow, 109263
    Russian Federation

    Site Not Available

  • Almazov's Federal Heart, Blood & Endocrinology Center

    St. Petersburg, 194156
    Russian Federation

    Site Not Available

  • Pavlov's State Medical University of St. Petersburg

    St. Petersburg, 197022
    Russian Federation

    Site Not Available

  • Department of Acute Myocardial Infarction

    Kharkov, 61039
    Ukraine

    Site Not Available

  • Department of Propedeutics of Internal Medicine No 1

    Kiev, 3049
    Ukraine

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Arizona Pulmonary Specialists

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • West Los Angeles VA HealthCare Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • University of Colorado Health Science Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Connecticut Health Center

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Atlanta Institute for Medical Research, Inc.

    Atlanta, Georgia 30030
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • BACH Cardiology/Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Washington University Medical Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University Medical Center

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Site Not Available

  • Mary Parkes Asthma Center University of Rochester

    Rochester, New York 14623
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Lexington Pulmonary and Critical Care Medicine

    Lexington, South Carolina 29072
    United States

    Site Not Available

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