NCT00862420

Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Peripheral Arterial Disease (PAD)

Interventions

Type	Name	Description
DRUG	clopidogrel (SR25990)	oral administration (tablets)
DRUG	ticlopidine	oral administration (tablets)

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-03-16
• Last updated: 2012-07-17

Locations

1 site across 1 country: Japan