Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-04-14 @ 7:19 AM
Study NCT ID:
NCT00862420
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2009-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg/Day Versus Ticlopidine 200 mg/Day in Patients With Peripheral Arterial Disease - With Extended Treatment of Clopidogrel 75 mg/Day for 40 Weeks
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Primary objective:
* To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD)
Secondary objectives:
* To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine
* To compare the risk of vascular events of clopidogrel with ticlopidine
* To document the long-term safety of clopidogrel for a total of 52 weeks
* To document the vascular events of clopidogrel for a total of 52 weeks
* To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD)
Secondary objectives:
* To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine
* To compare the risk of vascular events of clopidogrel with ticlopidine
* To document the long-term safety of clopidogrel for a total of 52 weeks
* To document the vascular events of clopidogrel for a total of 52 weeks
Detailed Description:
None
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?: