clinical trial · NCT00858637
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Chronic Kidney DiseaseMCI-196Placebo of SimvastatinSimvastatinPlacebo of MCI-196
brief summary
The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.
started
Mar 1, 2009
primary completion
Mar 1, 2010
completion
Mar 1, 2010
last updated
Jan 7, 2026
official title
A Phase III, Multicentre, Double-blind, Double-dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 Versus Simvastatin for the Treatment of Dyslipidaemia in Subjects With Chronic Kidney Disease on Dialysis (Incorporating a Placebo-controlled Withdrawal Phase)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol