NCT00423488

Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia
• Diabetes Mellitus, Type 2
• Coronary Disease

Interventions

Type	Name	Description
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	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
DRUG	Simvastatin Placebo	1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment

Timeline

• Start date: 2005-07-12
• Primary completion: 2007-02-16
• Completion: 2007-02-16
• First posted: 2007-01-18
• Last updated: 2022-02-09
• Results posted: 2010-03-09