Ignite Creation Date:
2024-05-06 @ 12:27 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01582438
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-01-29
First Post:
2012-04-19
Brief Title:
An Open Label Access Study For Subjects Who Completed A1481156
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
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
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 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
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