Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147316
Status:
COMPLETED
Last Update Posted:
2012-03-01
First Post:
2005-09-05
Brief Title:
Japan Alteplase Clinical Trial J-ACT Efficacy and Safety Study of Tissue Plasminogen Activator Alteplase for Ischemic Stroke
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Organization:
Mitsubishi Tanabe Pharma Corporation
Study Overview
Official Title:
Japan Alteplase Clinical Trial J-ACT Phase 3 Efficacy and Safety Study of Tissue Plasminogen Activator Alteplase for Acute Ischemic Stroke Within 3 Hours of Onset
Status:
COMPLETED
Status Verified Date:
2012-02
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:
Based on previous studies comparing Duteplasea recombinant tissue plasminogen activator rt-PA very similar to alteplase doses we performed a clinical trial with 06mgkg which is lower than the internationally approved dosage of 09mgkg aiming to assess the efficacy and safety of alteplase for the Japanese
Detailed Description:
Based on previous studies comparing Duteplase an rt-PA very similar to alteplase doses we performed a clinical trial with 06mgkg which is lower than the internationally approved dosage of 09mgkg aiming to assess the efficacy and safety of alteplase for the Japanese
The primary endpoints were the rate of patients with mRS score of 0-1 at 3 months and the incidence of sICH within 36 hours Thresholds for these endpoints were determined by calculating 90 confidence intervals of weighted averages derived from published reports The protocol was defined according to the National Institute of Neurological Disorders and Stroke NINDS rt-PA stroke study with slight modifications
The primary endpoints were the rate of patients with mRS score of 0-1 at 3 months and the incidence of sICH within 36 hours Thresholds for these endpoints were determined by calculating 90 confidence intervals of weighted averages derived from published reports The protocol was defined according to the National Institute of Neurological Disorders and Stroke NINDS rt-PA stroke study with slight modifications
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