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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00423488 |
Purpose
This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6 weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with doubling the dose of simvastatin to 40 mg alone in reducing low-density lipoprotein-cholesterol (LDL-C) concentrations and in achieving the National Cholesterol Expert Panel (NCEP) III LDL-C target goal of <2.6 mmol/L (<100 mg/dL) for subjects with diabetes mellitus and coronary heart disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Diabetes Mellitus, Type 2 Coronary Disease |
Drug: Ezetimibe 10 mg Drug: Simvastatin 20 mg Drug: Ezetimibe Placebo Drug: Simvastatin Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Parallel-Groups, Double-Blind Placebo Controlled Study Comparing the Efficacy, Safety, and Tolerability of Co-administration of Ezetimibe 10 mg With Ongoing Treatment With Simvastatin 20 mg Versus Doubling the Dose of Simvastatin in Subjects With Primary Hypercholesterolemia Diabetes Mellitus Type 2 and Coronary Heart Disease |
| Enrollment: | 93 |
| Study Start Date: | July 2005 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg
Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet.
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Drug: Ezetimibe 10 mg
1 x 10-mg tablet, provided as blinded study treatment
Drug: Simvastatin 20 mg
1 x 20-mg tablet, provided as open-label study treatment
Drug: Simvastatin Placebo
1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment
|
|
Active Comparator: Ezetimibe Placebo + Simvastatin 40 mg
Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet.
|
Drug: Simvastatin 20 mg
1 x 20-mg tablet, provided as open-label study treatment
Drug: Ezetimibe Placebo
1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment
Drug: Simvastatin 20 mg
1 x 20-mg tablet, provided as blinded study treatment
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00423488 History of Changes |
| Other Study ID Numbers: | P04037 |
| Study First Received: | January 17, 2007 |
| Results First Received: | February 17, 2010 |
| Last Updated: | March 17, 2010 |
| Health Authority: | Italy: AIFA Agenzia Italiana del Farmaco- Rome |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Heart Diseases Hypercholesterolemia Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Simvastatin Ezetimibe Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |