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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00050817 |
RATIONALE:
Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.
OBJECTIVES:
Condition | Intervention | Phase |
---|---|---|
Arteriosclerosis |
Drug: clopidogrel (SR25990) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-Blind Trial of Clopidogrel Versus Placebo in High-Risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-Dose ASA. |
Enrollment: | 15603 |
Study Start Date: | October 2002 |
Study Completion Date: | August 2005 |
TREATMENTS:
TREATMENT PLAN:
These study drugs will be administered on top of low-dose aspirin (75-162 mg qd) systematically prescribed to such patients. In addition, patients enrolled in CHARISMA will be managed as appropriate for their risk factors for atherosclerosis: eg. high blood pressure, high cholesterol, diabetes…etc.
PRIMARY ENDPOINT:
STUDY EXECUTION:
STUDY TERRITORY:
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION:
Be at least 45 years old and comply with at least one of the four categories of inclusion criteria:
Major atherothrombotic risk factors
Minor atherothrombotic risk factors
and/or
EXCLUSION:
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC4505 |
Study First Received: | December 20, 2002 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00050817 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Embolism |
Arterial Occlusive Diseases Aspirin Embolism Clopidogrel |
Vascular Diseases Platelet Aggregation Inhibitors Ischemia Arteriosclerosis |
Arterial Occlusive Diseases Therapeutic Uses Clopidogrel Hematologic Agents Vascular Diseases |
Platelet Aggregation Inhibitors Cardiovascular Diseases Arteriosclerosis Pharmacologic Actions |