A Local, Multicentre, 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 For Subjects In India

Pfizer, Ltd.0 个研究点目标入组 4 人开始时间: 2015年6月16日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•1. Subjects completed study A1481156 and are judged by the Investigator to derive clinical benefit from continuous treatment with sildenafil citrate therapy.
•2. Subjects with PAH being treated at a study site in India
•3. All female subjects of childbearing potential must use adequate contraception (i.e, hormonal in conjunction with intrauterine device or barrier methods with spermicide)
•throughout the study and for four weeks after completion of the study, or must be celibate or their partner must have had a vasectomy. The Visit 1 urine pregnancy test must be negative (if the urine pregnancy test is positive, a serum pregnancy test must be performed and the result must be negative). Female subjects who have been surgically sterilized may be enrolled and do not need to use birth control.
•4. Evidence of an informed consent document signed and dated by the subject (or a legally acceptable representative) indicating that the subject has been informed of all pertinent aspects of the study. Also, subject assent will be obtained where applicable.
•5. Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Pregnant or lactating female subjects.
•2. Current participation in other studies and during study participation, except for the A1481304 follow-up period. In case of discontinuation of therapy the patient will come for a follow-up visit for A1481304, but will no longer be being treated in A1481304.
•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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