At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Ezetimibe 10 mg, Simvastatin 20 mg, and 2 other interventions for Hypercholesterolemia and 2 related conditions. Completed, enrolled 93 participants.
Detailed Summary
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.
Study Details
Timeline
Interventions
1 x 10-mg tablet, provided as blinded study treatment
1 x 20-mg tablet, provided as open-label study treatment
1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment
1 x 20-mg tablet, provided as blinded study treatment
1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment