A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertensio
Phase 3
- Conditions
- Health Condition 1: null- Pulmonary Arterial Hypertension
- Registration Number
- CTRI/2009/091/000183
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
Ages Eligible for Study: 16 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Previously enrolled in B1321001 for at least 4 weeks.
Previously enrolled in B1321003, discontinued from the study.
Completed the B1321003 study as planned.
Exclusion Criteria
Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method