- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00862420
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease
July 16, 2012 updated by: Sanofi
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
431
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clopidogrel
75 mg clopidogrel once daily from Day 1 to Week 12
|
oral administration (tablets)
|
Active Comparator: Ticlopidine
200 mg ticlopidine once daily from Day 1 to Week 12
|
oral administration (tablets)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
Time Frame: Week 12 (on treatment)
|
Week 12 (on treatment)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bleeding adverse events, Serious adverse events, Overall safety
Time Frame: Week 12, 52 (on treatment)
|
Week 12, 52 (on treatment)
|
Vascular events
Time Frame: Week 12, 52 (on study)
|
Week 12, 52 (on study)
|
Safety events of interest (see above)
Time Frame: Week 52 (on treatment)
|
Week 52 (on treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hiroshi Shigematsu, Head Professor/MD/PhD, Second Department of Surgery (Vascular Surgery), Tokyo Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
March 9, 2009
First Submitted That Met QC Criteria
March 13, 2009
First Posted (Estimate)
March 16, 2009
Study Record Updates
Last Update Posted (Estimate)
July 17, 2012
Last Update Submitted That Met QC Criteria
July 16, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Clopidogrel
- Ticlopidine
Other Study ID Numbers
- SFY10810
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Disease (PAD)
-
Spectranetics CorporationRecruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | PAD | PAD - Peripheral Arterial Disease | Dissection | Arterial DissectionUnited States
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Alucent BiomedicalActive, not recruitingPAD - Peripheral Arterial DiseaseAustralia
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Alucent BiomedicalActive, not recruitingPAD - Peripheral Arterial DiseaseAustralia
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Vibrato Medical, Inc.Active, not recruitingPeripheral Arterial Disease (PAD)United States
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Cook Group IncorporatedCompletedPeripheral Arterial Disease (PAD)
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Cook Group IncorporatedCompleted
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Gardia MedicalCompletedPeripheral Arterial Disease (PAD)United States, Germany
-
Yonsei UniversityRecruitingPeripheral Arterial Disease(PAD)Korea, Republic of
-
Dallas VA Medical CenterTerminated
-
Medtronic EndovascularCompletedPeripheral Arterial Disease (PAD)Germany
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