Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202020
Status:
COMPLETED
Last Update Posted:
2006-03-16
First Post:
2005-09-12
Brief Title:
Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke
Sponsor:
Otsuka Beijing Research Institute
Organization:
Otsuka Beijing Research Institute
Study Overview
Official Title:
Cilostazol Stroke Prevention Study-a Randomized Double Blind Double Dummy Parallel Comparative Multicenter Clinical Trial
Status:
COMPLETED
Status Verified Date:
2006-03
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:
The study design is subject to relevant SFDA regulations about clinical trials This indication was approved in Japan in 2003
From the end of May 2004 to the end of Dec 2004 720 patients with previous cerebral infarctionsee the inclusion criteria were enrolled in to the study and received one of the two treatment regimens Cilostazol or Aspirin the ratio of patient number of each group is 11 For each patient the chance of entering either of these two groups is the same The treatment will continue till the end of 2005 During the treatment period patients will be observed concerning some certain events mainly reoccurrence of stroke If the patient experiences reoccurrence of stroke or other event that the doctors think it is not appropriate to continue the study medication this patient would stop the treatment Patients were also required to take MRI head scan before entering the study and on completion of the treatment
From the end of May 2004 to the end of Dec 2004 720 patients with previous cerebral infarctionsee the inclusion criteria were enrolled in to the study and received one of the two treatment regimens Cilostazol or Aspirin the ratio of patient number of each group is 11 For each patient the chance of entering either of these two groups is the same The treatment will continue till the end of 2005 During the treatment period patients will be observed concerning some certain events mainly reoccurrence of stroke If the patient experiences reoccurrence of stroke or other event that the doctors think it is not appropriate to continue the study medication this patient would stop the treatment Patients were also required to take MRI head scan before entering the study and on completion of the treatment
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