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| Sponsored by: |
Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00423579 |
Purpose
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Coronary Disease |
Drug: Ezetimibe/Simvastatin 10/20 mg Drug: simvastatin 40 mg |
Phase IV |
| 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, Randomized, Parallel-Groups, Double-Blind Placebo-Controlled Study Comparing the Efficacy, Safety, and Tolerability of Administration of Ezetimibe/Simvastatin Tablet 10/20 mg Versus Doubling the Dose of Simvastatin 20 mg [Simvastatin 40 mg] in Subjects With Primary Hypercholesterolemia and Coronary Heart Disease |
| Estimated Enrollment: | 190 |
| Study Start Date: | July 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Ezetimibe/Simvastatin 10/20 mg + Simvastatin placebo: Experimental
Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
|
Drug: Ezetimibe/Simvastatin 10/20 mg
1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks
|
|
Ezetimibe/Simvastatin placebo + Simvastatin 40 mg: Active Comparator
Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
|
Drug: simvastatin 40 mg
1 tablet containing 40 mg of simvastatin per day for 6 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
documented stable angina (with evidence of ischemia on exercise testing); history of myocardial infarction; history of percutaneous coronary intervention (primarily PCI with or without stent placement); symptomatic peripheral vascular disease (claudication); documented history of atherothrombotic cerebrovascular disease; and/or documented history of unstable angina or non-Q wave myocardial infarction.
Exclusion Criteria:
Exclusion Criteria: subjects who have the following medical conditions:
Exclusion Criteria: subjects who are on any of the following concomitant medications:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Patrizia Favini, MD - Medical Director, Italy Country Operations ) |
| Study ID Numbers: | P04039 |
| Study First Received: | January 17, 2007 |
| Last Updated: | May 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00423579 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
Antimetabolites Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Simvastatin Antilipemic Agents Myocardial Ischemia Vascular Diseases Ezetimibe |
Anticholesteremic Agents Ischemia Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Disease Metabolic Disorder Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |
|
Antimetabolites Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Myocardial Ischemia Vascular Diseases Enzyme Inhibitors Ezetimibe |
Anticholesteremic Agents Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Coronary Disease Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |