Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141011
Status:
TERMINATED
Last Update Posted:
2009-12-23
First Post:
2005-08-30
Brief Title:
Ancrod Viprinex for the Treatment of Acute Ischemic Stroke
Sponsor:
Neurobiological Technologies
Organization:
Neurobiological Technologies
Study Overview
Official Title:
ASP I Ancrod Stroke Program Study of Acute Viprinex for Emergency Stroke A Randomized Double-Blind Placebo-Controlled Study of Ancrod Viprinex in Subjects Beginning Treatment Within 6 Hours of the Onset of Acute Ischemic Stroke
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months
Detailed Description:
With prior approval by the FDA an interim analysis for futility was performed when 500 subjects had been entered into the two parallel trials NCT00141001 and NCT00300196 The analyses were reviewed by the data safety monitoring board which recommended that both studies be terminated because of futility This was done at a point where 650 subjects had been entered into both studies combined but analyses were conducted only on the initial 500 subjects Results of the abbreviated analysis will be found with study NCT00141001 since that study contributed most of the subjects to the analysis
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