Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080457
Status:
COMPLETED
Last Update Posted:
2007-11-09
First Post:
2004-04-01
Brief Title:
Safety and Efficacy Study of Sitaxentan Sodium Thelin in Patients With Pulmonary Arterial Hypertension
Sponsor:
Encysive Pharmaceuticals
Organization:
Encysive Pharmaceuticals
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Thelin Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Thelin sitaxsentan sodium compared to placebo sugar pill in the treatment of patients with pulmonary arterial hypertension PAH
Detailed Description:
The purpose of this study is to evaluate the safety and efficacy of Thelin sitaxsentan sodium as compared to placebo in the treatment of patients with PAH A cohort of patients will be randomized to usual treatment with Tracleer bosentan for observational comparisons of safety and efficacy
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