A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)

Study Overview
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Brief Summary
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Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.

Official Title
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A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: simvastatin (+) ezetimibe
* Drug: Comparator: atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement No history of diabetes and 100 <=LDL-C <=250 mg/dl Exclusion Criteria: Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months Congestive heart failure defined by New York Heart Association (NYHA) class III or IV Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins Uncontrolled hypertension Unstable angina

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vytorin®<br>simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks | Drug: simvastatin (+) ezetimibe<br>* simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks<br>* Other names: Vytorin®;|
| Active Comparator: atorvastatin<br>atorvastatin 10 mg; tablet, once daily, 8 Weeks | Drug: Comparator: atorvastatin<br>* atorvastatin 10 mg; tablet, once daily, 8 Weeks<br>* Other names: Lipitor®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. |  | Baseline and 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk). | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Disorder