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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	simvastatin (+) ezetimibe	simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
DRUG	Comparator: atorvastatin	atorvastatin 10 mg; tablet, once daily, 8 Weeks

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-07-04
• Last updated: 2024-05-16
• Results posted: 2009-11-17