Health Condition 1: null- Pulmonary Arterial Hypertension
Conditions
Interventions
Intervention1: Sildenafil citrate: 20 mg tablet taken orally three times a day as long as patient is clinically benefiting from treatment per Investigator discretion.
Control Intervention1: NA: There
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject who complete the A1481244 study and require Sildenafil 20 mg TID therapy. 2. All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study or be celibate or their partner must have had a vasectomy. The screening urine pregnancy tests should be negative (if the urine pregnancy test is positive, a serum pregnancy test should be performed and the result should be negative). Women who have been surgically sterilized or are at least two years menopausal may be enrolled and do not need to use birth control. 3. Subjects who are willing to and able to comply with scheduled visits and trial procedures. 4. Subjects who have been informed of all pertinent aspects of the trial and have given (personally signed and dated) written informed consent to participate in the study before being screened for the study
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Participation in other studies during study participation 3. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Provide access to Sildenafil therapy for subjects completing the A1481244 study & for subjects continuing in A1481269 study who continue to receive benefit from the therapy as deemed by the investigator. Safety and tolerability of Sildenafil in patients with PAH will be assessed based on adverse events.Timepoint: Provide access to Sildenafil therapy for subjects completing the A1481244 study & for subjects continuing in A1481269 study who continue to receive benefit from the therapy as deemed by the investigator. Safety and tolerability of Sildenafil in patients with PAH will be assessed based on adverse events. There is no time point in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomesTimepoint: NA | — |
Countries
India
Contacts
Public ContactSwapnali Raut
Representing Pfizer Limited
Outcome results
None listed