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

Chronic Kidney Disease Clinical Trial

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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00858637
Study type Interventional
Source Mitsubishi Tanabe Pharma Corporation
Contact
Status Completed
Phase Phase 3
Start date March 2009
Completion date March 2010
View Details
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