Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study
- Conditions
- Pulmonary Arterial Hypertension
- Registration Number
- NCT00878943
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
In an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Subject who complete the A1481244 study and require Sildenafil (Revatio TM) 20 mg TID therapy.
- All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study
Exclusion Criteria
- Pregnant or lactating women
- Participation in other studies during study participation
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
St Johns Medical College Hospital
🇮🇳Bangalore, Karnataka, India
Metro Multispeciality Hospital
🇮🇳Noida, Uttar Pradesh, India
The Institute of Medical Sciences, CARE Hospital
🇮🇳Hyderabad, Andra Pradesh, India
Mehta Hospital & Cardiopulmonary Care Center
🇮🇳Ahmedabad, Gujarat, India
Bankers Heart Institute
🇮🇳Vadodara, Gujarat, India