Overview
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)
Status:
Completed
Completed
Trial end date:
2008-08-01
2008-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Merck Sharp & Dohme Corp.Treatments:
Atorvastatin
Atorvastatin Calcium
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Simvastatin
Criteria
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