Status:
COMPLETED
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease
Lead Sponsor:
Sanofi
Conditions:
Peripheral Arterial Disease (PAD)
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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)...
Eligibility Criteria
Inclusion
- Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):
- Current intermittent claudication with Ankle Brachial Index (ABI) \< 0.90
- A history of intermittent claudication together with previous related intervention in a leg
Exclusion
- Patients who had acute atherothrombotic events or any invasive therapies within 30 days before the randomization, or patients who planned any invasive therapies within 12 weeks after the randomization
- Bleeding diathesis, coagulopathy and present bleeding disease
- Previous intracranial bleeding or hemorrhagic stroke
- Uncontrolled hypertension
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT00862420
Start Date
February 1 2009
End Date
May 1 2011
Last Update
July 17 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Tokyo, Japan