drugset / Trial / NCT00861731

Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy

NCT00861731

Phase 4 Unknown 30 enrolled Azienda Ospedaliero Universitaria di Sassari
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether, in patients with chronic proteinuric nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than statin alone to achieve the optimum lipid control, and if this translates to an improvement of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).

Timeline

Start
2008-11
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ezetimibe Unknown 10 mg
Comparator Simvastatin Small molecule 20 mg
Comparator Simvastatin Small molecule 40 mg