Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding Sildenafil
Phase 3
- Conditions
- Health Condition 1: null- Pulmonary Arterial Hypertension
- Registration Number
- CTRI/2009/091/000184
- 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 and completed the 12-week study as planned.
Exclusion Criteria
Treated with an investigational drug, other than sitaxsentan sodium in B1321001, 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