Study of Ambrisentan in Participants With Pulmonary Hypertension
Completed · Phase 3
Conditions studied: Pulmonary Hypertension
In brief
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.
Key facts
- Study ID
- NCT00777920
- Run by
- Gilead Sciences
- People needed
- 140
- Starts
- 2008-11-17
- Expected to finish
- 2019-09-11
- Last updated by the study team
- 2020-09-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Arizona Pulmonary Specialists — Phoenix, Arizona, United States
- University of Colorado Health Science Center — Aurora, Colorado, United States
- University of Connecticut Health Center — Farmington, Connecticut, United States
- Atlanta Institute for Medical Research, Inc. — Atlanta, Georgia, United States
- University of Iowa — Iowa City, Iowa, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- BACH Cardiology/Children's Hospital — Boston, Massachusetts, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- Boston University Medical Center — Boston, Massachusetts, United States
- Washington University Medical Center — St Louis, Missouri, United States
- Newark Beth Israel Medical Center — Newark, New Jersey, United States
- Mary Parkes Asthma Center University of Rochester — Rochester, New York, United States
- University of Pittsburgh Medical Center Presbyterian — Pittsburgh, Pennsylvania, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Lexington Pulmonary and Critical Care Medicine — Lexington, South Carolina, United States
- Clinica Independencia Munro — Buenos Aires, Argentina
- Instituto de Investigaciones Clínicas Mar del Plata — Buenos Aires, Argentina
- Sanatorio Otamendi y Miroli — Buenos Aires, Argentina
- Hospital Británico de Buenos Aires — Buenos Aires, Argentina
- UAI Hospital Universitario — Buenos Aires, Argentina
- Instituto de Cardiologia J.F. Cabral — Corrientes, Argentina
- Fundación Rusculleda — Córdoba, Argentina
- Instituto de Cardiologia Hospital Italiano de Cordoba — Córdoba, Argentina
- Hospital Privado Centro Medico de Cordoba S.A. — Córdoba, Argentina
Full record on ClinicalTrials.gov
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