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Clinical Trial Details

Trial ID: L0980
Source ID: NCT00542386
Associated Drug: Mci-196
Title: A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00542386/results
Conditions: Chronic Kidney Disease|Dialysis|Hyperphosphatemia|Dyslipidemia
Interventions: DRUG: MCI-196|DRUG: Placebo
Outcome Measures: Primary: The Change in Serum Phosphorus, The change from baseline to week 12, 12 weeks|The Change in LDL-cholesterol, The percentage change from baseline to week 12, 12 weeks | Secondary: The Change in Total-cholesterol, 12 weeks|The Change in HDL-cholesterol, 12 weeks|The Change in Triglycerides, 12 weeks|The Change in PTH, 12 weeks|The Change in Ca, 12 weeks|The Change in Ca x P Ion Product, 12 weeks|The Incidence of Adverse Events, 12 weeks
Sponsor/Collaborators: Sponsor: Mitsubishi Tanabe Pharma Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 642
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-12
Completion Date: 2009-11
Results First Posted: 2014-10-06
Last Update Posted: 2014-10-06
Locations: Ajka, Hungary|Baja, Hungary|Budapest, Hungary|Esztergom, Hungary|Gyor, Hungary|Hatvan, Hungary|Kisvarda, Hungary|Lecco, Italy|Modena, Italy|Pavia, Italy|Roma, Italy|Skopje, Macedonia, The Former Yugoslav Republic of|Alor Star, Malaysia|Ipoh, Malaysia|Kajang, Malaysia|Klang, Malaysia|Kota Kinabalu, Malaysia|Kuala Terengganu, Malaysia|Kuantan, Malaysia|Kuching, Malaysia|Melaka, Malaysia|Seremban, Malaysia|Taiping, Malaysia|Lodz, Poland|Plock, Poland|Poznan, Poland|Rybnik, Poland|Warszawa, Poland|Wroclaw, Poland|Zielona Gora, Poland|Arkhangelsk, Russian Federation|Armavir, Russian Federation|Chelyabinsk, Russian Federation|Chita, Russian Federation|Ekaterinburg, Russian Federation|Irkutsk, Russian Federation|Ivanovo, Russian Federation|Kaluga, Russian Federation|Kemerovo, Russian Federation|Khabarovsk, Russian Federation|Krasnodar, Russian Federation|Krasnoyarsk, Russian Federation|Moscow, Russian Federation|Nizhniy Novgorod, Russian Federation|Novokuznetsk, Russian Federation|Novorossiysk, Russian Federation|Novosibirsk, Russian Federation|Omsk, Russian Federation|Petrozavodsk, Russian Federation|Rostov-on Don, Russian Federation|Smolensk, Russian Federation|St. Petersburg, Russian Federation|Tomsk, Russian Federation|Tumen, Russian Federation|Tver, Russian Federation|Vladimir, Russian Federation|Vladivostok, Russian Federation|Volzhskiy, Russian Federation|Yaroslavl, Russian Federation|Belgrade, Serbia|Kragujevac, Serbia|NIS, Serbia|Novi Sad, Serbia|Chernivtsi, Ukraine|Dnepropetrovsk, Ukraine|Ivano-Frankivsk, Ukraine|Kharkiv, Ukraine|Kiev, Ukraine|Mykolaiv, Ukraine|Ternopil, Ukraine|Uzhgorod, Ukraine|Zaporizhya, Ukraine|Zhytomyr, Ukraine
URL: https://clinicaltrials.gov/show/NCT00542386

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress