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)

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: simvastatin (+) ezetimibe

• Registration Number: NCT00496730
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-02
• Study First Submitted QC: 2007-07-02
• Study First Posted: 2007-07-04
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-09-03
• Results First Submitted QC: 2009-10-14
• Results First Posted: 2009-11-17
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.	Baseline and 8 Weeks

Secondary Outcome Measures

Name	Time	Method
Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.	Baseline and 8 weeks	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).