Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-10-31

Brief Summary

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This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

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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

Ezetimibe 10 mg/Simvastatin 20 mg

Group Type EXPERIMENTAL

ezetimibe (+) simvastatin

Intervention Type DRUG

simvastatin/ezetimibe 10/20 mg

Atorvastatin

Atorvastatin 10 mg

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

atorvastatin 10 mg

Interventions

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ezetimibe (+) simvastatin

simvastatin/ezetimibe 10/20 mg

Intervention Type DRUG

atorvastatin

atorvastatin 10 mg

Intervention Type DRUG

Other Intervention Names

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MK0653A Vytorin® Lipitor®

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of hypercholesterolemia
* LDL-C \>/= 130 mg/dL but \</=250 mg/dL and triglyceride (TG) \</= 350 mg/dL
* National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline