drugset / Trial / NCT00932620

Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)

NCT00932620

Phase 4 Completed 100 enrolled University of Ioannina
RandomizedParallel-groupOpen-labelTreatment

Summary

Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein cholesterol (LDL-C) reductions of approximately the same magnitude. However, the differential effects of these two treatment options on small dense LDL-C (sdLDL-C) concentration have not been assessed. The aim of the present study is to compare the effects of simvastatin 40 mg versus simvastatin/ezetimibe 10/10 mg on sdLDL-C concentration. The primary efficacy endpoint will be changes in LDL subfraction profile (i.e. mean LDL particle size, sdLDL-C levels) at 3 months after treatment initiation.

Timeline

Start
2009-06
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ezetimibe Unknown 10 mg
Comparator Simvastatin Small molecule 10 mg
Comparator Simvastatin Small molecule 40 mg

Indications