Official Title
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
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.

Available
Individual Patients
Pulmonary Arterial Hypertension

Drug: sildenafil
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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 10 Years~Maximum: 30 Years
Countries
Russian Federation
Contacts

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer CT.gov Call Center
Study Director
Pfizer

EA Number
Keywords
sildenafil
pulmonary arterial hypertension
PAH
MeSH Terms
Hypertension
Familial Primary Pulmonary Hypertension
Sildenafil Citrate