A Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy

Pfizer Limited0 个研究点目标入组 27 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

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