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Clinical Trial Details

Trial ID: L0825
Source ID: NCT00506441
Associated Drug: Mci-196
Title: A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00506441/results
Conditions: Chronic Kidney Disease|Dialysis|Hyperphosphatemia
Interventions: DRUG: MCI-196|DRUG: Placebo
Outcome Measures: Primary: The Change in Serum Phosphorus From Week 12 to Week 16, The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12), 4 weeks (Week 12 to Week 16) | Secondary: Change From Baseline in Serum Phosphorus, 12 weeks (Week 0 to Week 12)|Change From Baseline in PTH, 12 weeks|Change From Baseline in Calcium, 12 weeks|Change From Baseline in Calcium x Phosphorus Ion Product, 12 weeks|Change From Baseline in Total Cholesterol, 12 weeks|Change From Baseline in LDL Cholesterol, 12 weeks|Change From Baseline in HDL Cholesterol, 12 weeks|Change From Baseline in VLDL Cholesterol, 12 weeks|Change From Baseline in Triglyceride, 12 weeks|Incidence of Adverse Events, 12 weeks (Week 0-12) and 4 weeks (Week 12-16)
Sponsor/Collaborators: Sponsor: Mitsubishi Tanabe Pharma Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 245
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-09
Completion Date: 2009-09
Results First Posted: 2014-07-25
Last Update Posted: 2014-09-15
Locations: Glendale, Arizona, United States|Tempe, Arizona, United States|Hot Springs, Arkansas, United States|Paragould, Arkansas, United States|Pine Bluff, Arkansas, United States|Fountain Valley, California, United States|La Mesa, California, United States|Long Beach, California, United States|Lynwood, California, United States|Orange, California, United States|San Diego, California, United States|Whittier, California, United States|Brandon, Florida, United States|Hudson, Florida, United States|Lauderdale Lakes, Florida, United States|Tampa, Florida, United States|Augusta, Georgia, United States|Decatur, Georgia, United States|Macon, Georgia, United States|Evanston, Illinois, United States|Evergreen Park, Illinois, United States|Fort Wayne, Indiana, United States|Shreveport, Louisiana, United States|Springfield, Massachusetts, United States|Eatontown, New Jersey, United States|Flushing, New York, United States|Springfield Gardens, New York, United States|Allentown, Pennsylvania, United States|Lewistown, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|Columbia, South Carolina, United States|Orangeburg, South Carolina, United States|Sumter, South Carolina, United States|San Antonio, Texas, United States|Alexandria, Virginia, United States|Portsmouth, Virginia, United States|Richmond, Virginia, United States|West Allis, Wisconsin, United States|San Juan, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00506441

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress