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)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Comparator: atorvastatin; Drug: simvastatin (+) ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00496730

2007_017

MK0653A-129

0653A-129

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

Vytorin®

Experimental group

Description:

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

Treatment:

Drug: simvastatin (+) ezetimibe

atorvastatin

Active Comparator group

Description:

atorvastatin 10 mg; tablet, once daily, 8 Weeks

Treatment:

Drug: Comparator: atorvastatin