A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
Phase 3
- Conditions
- Pulmonary Arterial Hypertension
- Registration Number
- JPRN-jRCT2080221332
- Lead Sponsor
- Pfizer Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
1.Has a current diagnosis of symptomatic PAH
2.Has 6MWT distances from 150 to 450 meters and distance
Exclusion Criteria
1.Previous exposure to an endothelin receptor antagonist
2.Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening
3.Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at Screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method