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NCT01582438 Clinical Trial

An Open Label Access Study For Subjects Who Completed A1481156

Pulmonary Arterial Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01582438
Other study ID # A1481304
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 12 Years to 30 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Access program - sildenafil citrate, Viagra, Revatio
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.

Locations
Country Name City State
India CARE Hospital Hyderabad Andhra Pradesh

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

India, 

See also
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Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
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