Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272909
Status:
TERMINATED
Last Update Posted:
2015-10-20
First Post:
2006-01-05
Brief Title:
Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging MRI
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase IIb Randomized Double-blind Placebo-Controlled Group-Sequential Multicenter Dose Finding Study of the Safety and Efficacy of SUN N4057 Piclozotan Administered for 72 Hours by Continuous Intravenous Infusion in Subjects With Acute Ischemic Stroke and Measurable Penumbra on MRI
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is designed to evaluate the safety tolerability and efficacy of SUN N4057 piclozotan in subjects with acute ischemic stroke within 9 hours of the onset of symptoms
Detailed Description:
The primary objective of the study is to determine the efficacy of a 72 hour infusion of SUN N4057 piclozotan in subjects with clinical findings of an acute ischemic stroke and a magnetic resonance imaging MRI demonstrating a measurable penumbra perfusion-weighted imaging PWI minus diffusion-weighted imaging DWI volume Efficacy will be determined by comparing the proportion of subjects with no growth in stroke lesion volume as assessed by DWI at Screening to stroke lesion volume assessed by FLAIR fluid-attenuated inversion recovery on Day 28 in the piclozotan group versus the placebo group
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