drugset / Trial / NCT00777920

Study of Ambrisentan in Participants With Pulmonary Hypertension

NCT00777920

Phase 3 Completed 140 enrolled Gilead Sciences
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-11-17
Primary completion
2019-09-11
Completion
2019-09-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ambrisentan Small molecule 2.5 mg Oral
Subject Ambrisentan Small molecule 5 mg Oral
Subject Ambrisentan Small molecule 10 mg Oral