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Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

NCT00862420 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2012-07-17

No results posted yet for this study

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

DRUG

clopidogrel (SR25990)

oral administration (tablets)

DRUG

ticlopidine

oral administration (tablets)

Sponsors & Collaborators

Principal Investigators

  • Hiroshi Shigematsu, Head Professor/MD/PhD · Second Department of Surgery (Vascular Surgery), Tokyo Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00862420 on ClinicalTrials.gov