Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
0653A-129
Description
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.
Trial arms
Trial start
2007-07-01
Estimated PCD
2008-08-01
Trial end
2008-08-01
Status
Completed
Phase
Early phase I
Treatment
simvastatin (+) ezetimibe
simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
Arms:
Vytorin®
Other names:
MK0653A, Vytorin®
Comparator: atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks
Arms:
atorvastatin
Other names:
Lipitor®
Size
256
Primary endpoint
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
Baseline and 8 Weeks
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 256, 'type': 'ACTUAL'}}
Updated at
2024-05-16

1 organization

2 products

1 indication

Organization
Organon and Co
Product
Simvastatin + Ezetimibe
Indication
Hypercholesterolemia
Product
Atorvastatin