At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 134 enrolled
Drug / intervention
ambrisentandrug
Likely dose
ambrisentan 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)
In Brief
A Phase 3 clinical trial evaluating ambrisentan for Vascular Disease. Completed, enrolled 134 participants across 12 sites.
Detailed Summary
This open label, single-arm, non-controlled, multicentre study will determine the effect of ambrisentan on exercise capacity (6MWT) in Chinese subjects with PAH. The study consists of a screening period of 4 weeks, a 12-week primary evaluation period (PEP) and a 12-week dose-adjustment period (DAP). Ambrisentan 5 mg will be administered to eligible subjects for 12 weeks (PEP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVascular Disease
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
First PostedMar 2013
Primary CompletionAug 2014
TodayJul 2026
First PostedMar 11, 2013
Enrollment StartDec 1, 2012
Primary CompletionAug 15, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.3 years ago
Interventions
ambrisentandrug
Ambrisentan 5 mg will be administered to eligible subjects for 12 weeks