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Sponsors and Collaborators: |
Schering-Plough Merck |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00202878 |
This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. If LDL-C response is inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, as appropriate, may be increased to 80 mg. Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and stroke.
Condition | Intervention | Phase |
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Hypercholesterolemia Myocardial Infarction |
Drug: ezetimibe/simvastatin Drug: simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT) |
Estimated Enrollment: | 18000 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ezetimibe/simvastatin: Experimental |
Drug: ezetimibe/simvastatin
ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation (if LDL-C response is inadequate, the dose of simvastatin may be increased to 80 mg)
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simvastatin: Active Comparator |
Drug: simvastatin
simvastatin 40 mg per day from randomization through the end of participation (if LDL-C response is inadequate, the dose of simvastatin may be increased to 80 mg)
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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:
United States, Massachusetts | |
TIMI Study Group | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Amy McCagg 800-385-4444 amccagg@partners.org |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04103 |
Study First Received: | September 13, 2005 |
Last Updated: | August 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00202878 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hypercholesterolemia myocardial infarction cholesterol |
randomized controlled trials acute coronary syndrome angina |
Antimetabolites Hyperlipidemias Metabolic Diseases Heart Diseases Simvastatin Antilipemic Agents Myocardial Ischemia Vascular Diseases Angina Pectoris Ezetimibe Anticholesteremic Agents |
Ischemia Hydroxymethylglutaryl-CoA Reductase Inhibitors Necrosis Acute Coronary Syndrome Infarction Metabolic Disorder Myocardial Infarction Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Ezetimibe Necrosis Pathologic Processes Syndrome Therapeutic Uses Cardiovascular Diseases Myocardial Infarction Hypercholesterolemia Dyslipidemias Metabolic Diseases Hyperlipidemias |
Heart Diseases Disease Simvastatin Antilipemic Agents Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Ischemia Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Acute Coronary Syndrome Infarction Lipid Metabolism Disorders |