Overview

Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

Status:
Completed

Trial end date:
2010-03-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Mitsubishi Tanabe Pharma Corporation

Treatments:

Bile Acids and Salts
Simvastatin