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

Study Timeline

• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22

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

Trial Locations

Locations (1)

Moscow Research Institute of Pediatrics and Pediatric Surgery; 🇷🇺 Moscow, Russian Federation