Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-31 @ 6:42 PM
Study NCT ID:
NCT01603667
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2012-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PG2 Injection 500 mg in Acute Stroke Study (Pass)
Sponsor:
China Medical University Hospital
Organization:
Study Overview
Official Title:
PG2 Injection 500 mg in Acute Stroke Study (Pass): A Randomized, Double-Blind, Placebo-Controlled Study of PG2 Injection 500 mg in Patients With Treatment Started Within 3-6 Hrs of the Onset of Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2016-11
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:
Pass
Brief Summary:
The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.
The secondary objectives are as follows:
* To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel Index (BI) score at Day 90.
* To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent stroke, cardiovascular events and death of all causes.
* To evaluate the safety of PG2 Injection 500 mg treatment
The secondary objectives are as follows:
* To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel Index (BI) score at Day 90.
* To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent stroke, cardiovascular events and death of all causes.
* To evaluate the safety of PG2 Injection 500 mg treatment
Detailed Description:
Randomized, double-blind, placebo-controlled multi-center study of intravenous (IV) PG2 Injection 500 mg starting within 3-6 hrs of the onset of acute ischemic stroke
Study Oversight
Has Oversight DMC:
True
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?: