Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034307
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2002-04-24
Brief Title:
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
Sponsor:
ICOS-Texas Biotechnology
Organization:
ICOS-Texas Biotechnology
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Status:
UNKNOWN
Status Verified Date:
2002-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension patients with NYHA functional class II III or IV The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan compared to placebo inactive treatment for the treatment of pulmonary arterial hypertension Patients who complete this trial may be eligible to take part in an extension trial Protocol FPH01-X Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial
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