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Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil

A LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, 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 RUSSIAN FEDERATION

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01897740
Enrollment
Unknown
Registered
2013-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

sildenafil, pulmonary arterial hypertension, PAH

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.

Interventions

DRUGsildenafil

tablets of sildenafil 20 mg 3 times a day for subjects with body weight \> 20 kg and 10 mg TID for subjects with body weight ≤ 20 kg. If subject is 18 years of age or older, the recommended dose is 20 mg TID, regardless of body weight.

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
10 Years to 30 Years
Healthy volunteers
No

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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026