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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-08-31

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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vytorin®

simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks

Group Type EXPERIMENTAL

simvastatin (+) ezetimibe

Intervention Type DRUG

simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks

atorvastatin

atorvastatin 10 mg; tablet, once daily, 8 Weeks

Group Type ACTIVE_COMPARATOR

Comparator: atorvastatin

Intervention Type DRUG

atorvastatin 10 mg; tablet, once daily, 8 Weeks

Interventions

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simvastatin (+) ezetimibe

simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks

Intervention Type DRUG

Comparator: atorvastatin

atorvastatin 10 mg; tablet, once daily, 8 Weeks

Intervention Type DRUG

Other Intervention Names

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MK0653A Vytorin® Lipitor®

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No