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Sponsored by: |
Schering-Plough |
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00423488 |
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 |
Genetics Home Reference related topics: | hypercholesterolemia |
MedlinePlus related topics: | Cholesterol Diabetes Heart Diseases |
Drug Information available for: | Simvastatin Ezetimibe |
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 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | P04037 |
First Received: | January 17, 2007 |
Last Updated: | May 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00423488 |
Health Authority: | Italy: AIFA Agenzia Italiana del Farmaco- Rome |
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