Ignite Creation Date:
2024-05-05 @ 9:21 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00866983
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-02-01
First Post:
2009-03-20
Brief Title:
Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
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
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None