A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.
This study has been completed.
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First received: January 17, 2007
Last updated: April 15, 2009
Last verified: April 2009
A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo.
Secondary Outcome Measures:
- Change from baseline measured after 12 weeks of treatment compared to placebo in the Borg Dyspnea Index immediately following exercise, WHO functional class and SF-36 Health Survey.
- Clinical worsening of PAH.
- Assessment of the safety and tolerability of the study drug.
|Study Start Date:||December 2003|
|Estimated Study Completion Date:||October 2005|
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