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NCT01897740 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01897740
Other study ID # A1481307
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date December 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 10 Years to 30 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Russian Federation Moscow Research Institute of Pediatrics and Pediatric Surgery Moscow

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Russian Federation, 

See also
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