Overview

An Open Label Access Study For Subjects Who Completed A1481156

Status:
No longer available
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to provide sildenafil therapy to subjects who have completed the A1481156 study for the treatment of Pulmonary Arterial Hypertension (PAH) in India and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil citrate. Sildenafil citrate will be supplied for the treatment of Pulmonary Arterial Hypertension (PAH) until the subject continues to derive benefits from the treatment. The treating physicians (and the sponsor) will be responsible for reporting serious adverse events.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Citric Acid
Sildenafil Citrate
Sodium Citrate
Criteria
Inclusion Criteria:

- Subjects who have completed study A1481156 and are judged by the Investigator to
derive clinical benefit from continuous treatment with sildenafil citrate therapy.

- Subjects with pulmonary arterial hypertension (PAH ) being treated at a study site in
India

- Subjects who are willing and able to comply with scheduled visits, treatment plan, and
other study procedures

Exclusion Criteria:

- Pregnant or lactating female subjects.

- Current participation in other studies and during study participation, except for the
A1481304 follow-up period.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration and, in the judgment of the investigator, would
make the subject inappropriate for entry into this study.