Ignite Creation Date:
2024-05-05 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00796666
Status:
TERMINATED
Last Update Posted:
2015-03-24
First Post:
2008-11-20
Brief Title:
Study Looking at Combination Therapy SitaxsentanSildenafil Vs Monotherapy Sitaxsentan Alone SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 3 Multi-Center Randomized Double-Blind Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 NCT00795639
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Safety Issue The trial was prematurely terminated on Dec 9 2010 due to safety concerns specifically new emerging evidence of hepatic injury
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As monotherapy for pulmonary arterial hypertension PAH begins to fail additional therapies are introduced Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safetyefficacy database of the combination is limited
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