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Clinical Trial Details

Trial ID: L0248
Source ID: NCT00858637
Associated Drug: Mci-196
Title: Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00858637/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: MCI-196|DRUG: Placebo of Simvastatin|DRUG: Simvastatin|DRUG: Placebo of MCI-196
Outcome Measures: Primary: Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2), Percent Change from Week 16 to Week 20 (LOCF), week20 minus week16 | Secondary: Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1), Percent Change from Baseline to Week 16 (LOCF), week16 minus week0|Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH), 16 weeks and 20 weeks|Vital Signs, Adverse Events, and Laboratory Values, throughout study
Sponsor/Collaborators: Sponsor: Mitsubishi Tanabe Pharma Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 260
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-03
Completion Date: 2010-03
Results First Posted: 2014-10-17
Last Update Posted: 2014-12-30
Locations: Brest, Belarus|Gomel, Belarus|Grodno, Belarus|Minsk, Belarus|Vitebsk, Belarus|Gabrovo, Bulgaria|Plovdiv, Bulgaria|Sofia, Bulgaria|Karlovac, Croatia|Osijek, Croatia|Esbjerg, Denmark|Roskilde, Denmark|Jakarta, Indonesia|Malang, Indonesia|Medan, Indonesia|Palembang, Indonesia|Tamanlarea Makassar, Indonesia|Ashkelon, Israel|Nahariya, Israel|Bellano, Italy|Catania, Italy|Lecco, Italy|Merate, Italy|Milano, Italy|Oggiono, Italy|Riga, Latvia|Valmiera, Latvia|Kaunas, Lithuania|Kedauniai, Lithuania|Vilnius, Lithuania|Johor, Malaysia|Kelantan, Malaysia|Penang, Malaysia|Perak, Malaysia|Bucharest, Romania|Timisoara, Romania|Singapore, Singapore|Bangkok, Thailand|Phitsanulok, Thailand
URL: https://clinicaltrials.gov/show/NCT00858637

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D184 Simvastatin small molecule DB00641 Details