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

PHASE3CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Chronic Kidney Disease
Interventions
DRUG

MCI-196

Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

DRUG

Placebo of Simvastatin

Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

DRUG

Simvastatin

Tablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

DRUG

Placebo of MCI-196

Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Trial Locations (39)

Unknown

Brest

Grodno

Homyel

Minsk

Vitebsk

Gabrovo

Plovdiv

Sofia

Karlovac

Osijek

Esbjerg

Roskilde

Jakarta

Malang

Medan

Palembang

Tamanlarea Makassar

Ashkelon

Nahariya

Bellano

Catania

Lecco

Merate

Milan

Oggiono

Riga

Valmiera

Kaunas

Kedauniai

Vilnius

George Town

Johor Bahru

Kelantan

Perak

Bucharest

Timișoara

Singapore

Bangkok

Phitsanulok

All Listed Sponsors
lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY