|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 Drug: simvastatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo 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 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 |
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
| Study ID Numbers: | P04037 |
| Study First Received: | January 17, 2007 |
| Last Updated: | May 14, 2007 |
| ClinicalTrials.gov Identifier: | NCT00423488 History of Changes |
| Health Authority: | Italy: AIFA Agenzia Italiana del Farmaco- Rome |
|
Antimetabolites Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Ezetimibe Arteriosclerosis Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Arterial Occlusive Diseases Metabolic Diseases Heart Diseases Hyperlipidemias Simvastatin |
Antilipemic Agents Vascular Diseases Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Coronary Disease Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Coronary Artery Disease Lipid Metabolism Disorders |