Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil
A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.
1 other identifier
expanded_access
N/A
1 country
2
Brief Summary
The purpose of this study is to provide sildenafil therapy to patients who completed the A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil. It will be supplied until patient gets access to Sildenafil through Brazilian State Health Secretary from where patient resides.
Trial Health
Trial Health Score
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2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2009
CompletedFirst Posted
Study publicly available on registry
March 23, 2009
CompletedFebruary 1, 2021
January 1, 2021
March 20, 2009
January 28, 2021
Conditions
Keywords
Interventions
To provide access to sildenafil for patients completing the A1481244 study, resides in Brazilian States where Revatio™ is not supplied by Health Secretary and are judged by the Investigator to derive clinical benefit from continued treatment with sildenafil. It will be supplied until the patient gets access to Sildenafil through Brazilian State Health Secretary from where the patient resides.
Eligibility Criteria
You may qualify if:
- Subject who completed the A1481244 study and are judged by the Investigator to derive clinical benefit from continuous treatment with Sildenafil 20 mg therapy.
- Subject who resides in a Brazilian State where Sildenafil is not supplied by State Health Secretary.
You may not qualify if:
- Pregnant or lactating women.
- Current participation in other studies and during study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, 04012-909, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2009
First Posted
March 23, 2009
Last Updated
February 1, 2021
Record last verified: 2021-01