Clinical Trial Details
| Trial ID: | L0504 |
| Source ID: | NCT00416520 |
| Associated Drug: | Mci-196 (Colestilan(Inn), Colestimide(Jan), Cholebine®) |
| Title: | A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00416520/results |
| Conditions: | Chronic Kidney Disease|Hyperphosphatemia |
| Interventions: | DRUG: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)|DRUG: Placebo|DRUG: Another phosphate binder (Sevelamer) |
| Outcome Measures: | Primary: Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2), ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks., week16 minus week12 | Secondary: Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1), ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication., week12 minus week0 |
| Sponsor/Collaborators: | Sponsor: Mitsubishi Tanabe Pharma Corporation |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 336 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-06 |
| Completion Date: | 2009-11 |
| Results First Posted: | 2014-10-23 |
| Last Update Posted: | 2014-11-04 |
| Locations: | Adelaide, Australia|Nedlands, Australia|Parkville, Australia|St Leonards, Australia|Sydney, Australia|Woolloongabba, Australia|Graz, Austria|Frydek-Mistek, Czech Republic|HradecKralove, Czech Republic|Ostrava, Czech Republic|Praha, Czech Republic|Tabor, Czech Republic|Usti nad Labem, Czech Republic|Bordeaux, France|Montpelier, France|Paris, France|Aachen, Germany|Aschaffenburg, Germany|Coburg, Germany|Coesfeld, Germany|Darmstadt, Germany|Dieburg, Germany|Dortmund, Germany|Dusseldorf, Germany|Hamburg, Germany|Homberg - Efze, Germany|Langen, Germany|Mannheim-Kafertal, Germany|Munchen, Germany|Potsdam-Babelsberg, Germany|Baja, Hungary|Budapest, Hungary|Kisvarda, Hungary|Veszprem, Hungary|Biella, Italy|Como, Italy|Cremona, Italy|Lecco, Italy|Livorno, Italy|Milan, Italy|Pavia, Italy|Perugia, Italy|Rome, Italy|Ciechanow, Poland|Czestochowa, Poland|Gdansk, Poland|Krakow, Poland|Lodz, Poland|Lublin, Poland|Oswiecim, Poland|Pabianice, Poland|Rybnik, Poland|Sokolow Podlaski, Poland|Starogard Gdanski, Poland|Warszawa, Poland|Wejherowo, Poland|Zgierz, Poland|Zielona Gora, Poland|Cape Town, South Africa|Durban, South Africa|Gauteng, South Africa|Johannesburg, South Africa|Port Elizabeth, South Africa|Barcelona, Spain|Oviedo, Spain|Sevilla, Spain|Glasgow, United Kingdom|Stevenage, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00416520 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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