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Clinical Trial Details

Trial ID: L0323
Source ID: NCT00440648
Associated Drug: Sevelamer Carbonate, Sevelamer Hydrochloride
Title: Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: sevelamer carbonate, sevelamer hydrochloride|DRUG: sevelamer hydrochloride, sevelamer carbonate
Outcome Measures: Primary: Safety-evaluated on the basis of adverse events (reported and/or observed), 16 weeks|changes in laboratory parameters, vital signs, 16 weeks|note: clinically significant changes in physical examination were recorded and evaluated as adverse events, 16 weeks|Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period, 16 weeks|Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period., 16 weeks |
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2005-03
Completion Date: 2006-07
Results First Posted:
Last Update Posted: 2014-03-19
Locations: Mobile, Alabama, 36608, United States|Riverside, California, 92501, United States|Greenwood Village, Colorado, 80111, United States|Berwyn, Illinois, 60402, United States|Crestwood, Illinois, 60445, United States|Indianapolis, Indiana, 46202, United States|Valparaiso, Indiana, 46383, United States|Columbus, Missouri, 39705, United States|St. Louis, Missouri, 63103, United States|St. Louis, Missouri, 63110, United States|Winston-Salem, North Carolina, 27157, United States|Easton, Pennsylvania, 19045, United States|Wynnewood, Pennsylvania, 19096, United States|Nashville, Tennessee, 37205, United States|Norfolk, Virginia, 23507, United States
URL: https://clinicaltrials.gov/show/NCT00440648

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress