drugset / Trial / NCT00496730

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)

NCT00496730 ↗

Phase 3 Completed 256 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-07
Primary completion
2008-08
Completion
2008-08

Outcome

Met primary endpoint

registry analysis (unspecified test); Vytorin vs Atorvastatin; p <0.0001; ANCOVA NCT00496730 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 10 mg —
Subject Ezetimibe Unknown 20 mg —
Subject Simvastatin Small molecule 10 mg —

Indications