drugset / Trial / NCT00166504

Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

NCT00166504 ↗

Phase 4 Completed 203 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

Timeline

Start
2005-10
Primary completion
2007-10
Completion
2007-10

Outcome

Met primary endpoint

registry analysis (unspecified test); Vytorin vs Atorvastatin; p <0.001; Mean Difference (Net) -10 (95% CI -14.3 to -5.7); ANOVA NCT00166504 ↗

Drugs

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

Indications