Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil
- Conditions
- Pulmonary Arterial Hypertension
- Registration Number
- NCT01897740
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this study is to provide Sildenafil therapy for subjects who completed A1481156 study and are judged by the investigator to derive clinical benefit from continued treatment with Sildenafil, prior to reimbursement and availability for subjects in the Russian Federation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients Who Completed study A1481156 and Are Judged by the Investigator to Derive Clinical Benefit from Continued Treatment with Sildenafil, Prior to Reimbursement and Availability for Subjects in Russian Federation.
- Child bearing age women should have appropriate contraception.
- Signed informed consent. Patients who have a wish and possibility to follow treatment regimens in terms of the study.
Exclusion Criteria
- Pregnant and lactating women.
- Participation in other studies in the current moment or during study period except of A1481156.
- Patients with severe acute or chronic diseases psychiatric disorders or laboratory abnormalities.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Sildenafil in treating Pulmonary Arterial Hypertension in the Russian Federation?
How does Sildenafil compare to standard-of-care treatments for Pulmonary Arterial Hypertension in terms of efficacy and safety?
What biomarkers are associated with clinical benefit from Sildenafil therapy in Pulmonary Arterial Hypertension patients?
What are the known adverse events of Sildenafil in long-term therapy for Pulmonary Arterial Hypertension and their management strategies?
What is the role of Sildenafil in combination with other vasodilators for Pulmonary Arterial Hypertension treatment in expanded access programs?
Trial Locations
- Locations (1)
Moscow Research Institute of Pediatrics and Pediatric Surgery
🇷🇺Moscow, Russian Federation