Phase 3
Completed N=256
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)
Source: ClinicalTrials.gov NCT00496730 ↗Enrolled (actual)
256
Serious AEs
—
Results posted
Nov 2009
Primary outcomePrimary: Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. — -49.29; -38.05 Percent of Baseline Value — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. |
-49.29; -38.05 | <0.0001 sig |
| SECONDARY Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. |
105; 93 | <0.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT00496730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.