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Study of Ambrisentan in Subjects With Pulmonary Hypertension

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: Ambrisentan (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Gilead Sciences

Summary

This Phase 3, international, multicenter, open-label study will monitor the long-term safety of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan in the United States, Canada, and the European Union are 5 and 10 mg. 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.

Clinical Details

Official title: ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence and severity of adverse events (AEs) associated with long-term exposure to ambrisentan in participants with pulmonary hypertension

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women with pulmonary hypertension (PH) who are discontinuing a clinical study

of ambrisentan due to study closure by the Sponsor. Eligible subjects are those participating in countries where ambrisentan is not yet commercially available. Subjects participating in countries where ambrisentan is commercially available may be eligible if they do not qualify for treatment per the current prescribing information of that country. Exclusion Criteria:

- Subjects who have discontinued an ambrisentan clinical study for any other reason

than Sponsor-initiated study closure are not eligible.

Locations and Contacts

Clinica Independencia Munro, Buenos Aires 1605, Argentina

Hospital Británico de Buenos Aires, Buenos Aires C1280AEB, Argentina

Instituto de Investigaciones Clínicas Mar del Plata, Buenos Aires B7600FZN, Argentina

Sanatorio Otamendi y Miroli, Buenos Aires C1115AAb, Argentina

UAI Hospital Universitario, Buenos Aires C1437BZL, Argentina

Fundación Rusculleda, Cordoba X5003DCE, Argentina

Hospital Privado Centro Medico de Cordoba S.A., Cordoba X5016KEH, Argentina

Instituto de Cardiologia Hospital Italiano de Cordoba, Cordoba X5004FJE, Argentina

Instituto de Cardiologia J.F. Cabral, Corrientes W3400AMZ, Argentina

Hospital Italiano, Rosario S2001ODA, Argentina

Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME, Belo Horizonte 30380-090, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre 92020-090, Brazil

UBEA, Hospital Sao Lucas de Pontifícia, Porto Alegre 90610 000, Brazil

Hospital Universitario Clementino Fraga Filho, Rio de Janeiro 21949-900, Brazil

Hospital das Clinicas da FMUSP, Sao Paulo CEP05403-000, Brazil

Universidade do Estado de Sao Paulo - UNIFESP, Sao Paulo 4023-062, Brazil

Centro de Estudios Cardiologicos Santiago Oriente, Santiago 7500503, Chile

Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago 8330074, Chile

Instituto Nacional del Torax, Santiago 7500691, Chile

Instituto Nacional de Cardiologia Ignacio Chavez, Delegacion Tlalpan Distrito Federal 14080, Mexico

Unidad de Investigacion Clinica en Medicina S.C., Monterrey 64718, Mexico

Russian Cardiology Research Complex, Moscow 121552, Russian Federation

State Medico Stomatologic University, Moscow 109263, Russian Federation

Almazov's Federal Heart, Blood & Endocrinology Center, St. Petersburg 194156, Russian Federation

Pavlov's State Medical University of St. Petersburg, St. Petersburg 197022, Russian Federation

Department of Acute Myocardial Infarction, Kharkov 61039, Ukraine

Department of Propedeutics of Internal Medicine No 1, Kiev 3049, Ukraine

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Peter Lougheed Centre, Calgary, Alberta T1Y 6J4, Canada

Respiratory Research Peter Lougheed Centre, Calgary, Alberta T1Y6J4, Canada

University of Alberta Hospitals, Edmonton, Alberta T6G 2B7, Canada

Arizona Pulmonary Specialists, Phoenix, Arizona 85013, United States

West Los Angeles VA HealthCare Center, Los Angeles, California 90073, United States

University of Colorado Health Science Center, Aurora, Colorado 80045, United States

University of Connecticut Health Center, Farmington, Connecticut 06030, United States

Atlanta Institute for Medical Research, Inc., Atlanta, Georgia 30030, United States

University of Iowa, Iowa City, Iowa 52242, United States

BACH Cardiology/Children's Hospital, Boston, Massachusetts 02115, United States

Boston University Medical Center, Boston, Massachusetts 02118, United States

Brigham & Women's Hospital, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Tufts Medical Center, Boston, Massachusetts 02111, United States

Washington University Medical Center, St. Louis, Missouri 63110, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

St. Vincent's Hospital, Darlinghurst, New South Wales 2010, Australia

Mary Parkes Asthma Center University of Rochester, Rochester, New York 14623, United States

University of Rochester, Rochester, New York 14623, United States

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada

University of Pittsburgh Medical Center Presbyterian, Pittsburgh, Pennsylvania 15213, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Lexington Pulmonary and Critical Care Medicine, Lexington, South Carolina 29072, United States

Fiona Stanley Hospital, Murdoch, Western Australia 6150, Australia

Royal Perth Hospital, Perth, Western Australia 6001, Australia

Additional Information

Starting date: June 2008
Last updated: June 16, 2015

Page last updated: August 23, 2015

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