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Sponsored by: |
Otsuka Pharmaceutical Co., Ltd. |
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Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00234065 |
The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).
Condition | Intervention | Phase |
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Cerebral Infarction |
Drug: Cilostazol Drug: Aspirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Post-Marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin |
Enrollment: | 2800 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
cilostazol
|
Drug: Cilostazol
oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
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2: Active Comparator
Aspirin
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Drug: Aspirin
oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
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Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | OPCJ ( Katsuhisa Saito ) |
Study ID Numbers: | C02100-002, JapicCTI-050034, UMIN-CTR-C000000129 |
Study First Received: | October 4, 2005 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00234065 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Cilostazol Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Recurrence Necrosis Aspirin Brain Ischemia Brain Infarction Infarction |
Anti-Inflammatory Agents Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Neuroprotective Agents Fibrin Modulating Agents Pathologic Processes Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics |
Nervous System Diseases Cyclooxygenase Inhibitors Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Analgesics, Non-Narcotic Autonomic Agents Platelet Aggregation Inhibitors Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Bronchodilator Agents |