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Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)
|ClinicalTrials.gov Identifier: NCT00423488|
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : March 9, 2010
Last Update Posted : September 21, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Diabetes Mellitus, Type 2 Coronary Disease||Drug: Ezetimibe 10 mg Drug: Simvastatin 20 mg Drug: Ezetimibe Placebo Drug: Simvastatin Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2005|
|Primary Completion Date :||February 2007|
|Study Completion Date :||February 2007|
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Cholesterol Cholesterol Levels: What You Need to Know Cholesterol Medicines Coronary Artery Disease Heart DiseasesU.S. FDA Resources
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.
Drug: Ezetimibe 10 mg
1 x 10-mg tablet, provided as blinded study treatmentDrug: Simvastatin 20 mg
1 x 20-mg tablet, provided as open-label study treatmentDrug: 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 treatmentDrug: Ezetimibe Placebo
1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatmentDrug: Simvastatin 20 mg
1 x 20-mg tablet, provided as blinded study treatment
Primary Outcome Measures :
- Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint, After 6 Weeks of Treatment [ Time Frame: 6 weeks of treatment (from Baseline to Endpoint) ]
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