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Sponsors and Collaborators: |
Schering-Plough The TIMI Study Group Duke University |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00617123 |
This study is designed to evaluate the long-term ocular safety of SCH 530348 in subjects with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737).
Condition | Intervention | Phase |
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Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident |
Drug: SCH 530348 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study) |
Estimated Enrollment: | 200 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SCH 530348: Experimental |
Drug: SCH 530348
2.5-mg tablet daily for at least 1 year
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Placebo: Placebo Comparator |
Drug: Placebo
matching tablet daily for at least 1 year
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The study will include subjects who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05183 |
Study First Received: | February 4, 2008 |
Last Updated: | August 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00617123 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Cerebral Infarction Myocardial Ischemia Stroke Vascular Diseases Central Nervous System Diseases Ischemia |
Arteriosclerosis Brain Diseases Cerebrovascular Disorders Necrosis Neoplasm Metastasis Brain Ischemia Brain Infarction Infarction Myocardial Infarction |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Cerebral Infarction Myocardial Ischemia Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Ischemia |
Arteriosclerosis Brain Diseases Cerebrovascular Disorders Necrosis Pathologic Processes Brain Ischemia Cardiovascular Diseases Brain Infarction Infarction Myocardial Infarction |