Ignite Creation Date:
2024-05-05 @ 9:02 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00796510
Status:
TERMINATED
Last Update Posted:
2018-10-25
First Post:
2008-11-20
Brief Title:
Study Providing Monotherapy Sitaxsentan And Combination Therapy SitaxsentanSildenafil To Subjects With Pulmonary Arterial Hypertension PAH To Assess Long-Term Safety
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 3 Multi-Center Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2018-09
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 sitaxsentan is the agent most highly selective for ETA Endothelin Type A receptor and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension PAH therapy is these two oral drugs administered in combination
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