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An Open Label Access Study For Subjects Who Completed A1481156

Expanded access is currently available for this treatment.
Verified November 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01582438
First received: April 19, 2012
Last updated: November 19, 2014
Last verified: November 2014

April 19, 2012
November 19, 2014
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Complete list of historical versions of study NCT01582438 on ClinicalTrials.gov Archive Site
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An Open Label Access Study For Subjects Who Completed A1481156
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

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.

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Expanded Access
Phase 3
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Pulmonary Arterial Hypertension
Drug: Access program
The recommended dose is 20 mg TID 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. If a subject was receiving a higher dose in study A1481156 and the investigator believes that the subject requires continued treatment on that dose, or if dose reduction is judged to be associated with pulmonary arterial hypertension (PAH) deterioration in a particular subject, the higher dose may be made available, as judged on an individual basis on discussion with the sponsor.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
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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.
Both
12 Years to 30 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
India
 
NCT01582438
A1481304
No
Pfizer
Pfizer
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Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP