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Sponsored by: |
Mitsubishi Tanabe Pharma Corporation |
Information provided by: | Mitsubishi Tanabe Pharma Corporation |
ClinicalTrials.gov Identifier: | NCT00451295 |
This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.
Condition | Intervention | Phase |
Chronic Kidney Disease Dialysis Hyperphosphatemia |
Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia. |
Estimated Enrollment: | 200 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator |
Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
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2: Experimental |
Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Information at Mitsubishi Pharama Europe | information@mitsubishi-pharma.eu |
Czech Republic | |||||
Recruiting | |||||
Ostrava, Czech Republic | |||||
Recruiting | |||||
Frydek-Mistek, Czech Republic | |||||
France | |||||
Recruiting | |||||
Bordeaux, France | |||||
Recruiting | |||||
Montpelier, France | |||||
Germany | |||||
Recruiting | |||||
Coburg, Germany | |||||
Recruiting | |||||
Aachen, Germany | |||||
Italy | |||||
Recruiting | |||||
Lecco, Italy | |||||
Recruiting | |||||
Pavia, Italy | |||||
Recruiting | |||||
Milan, Italy | |||||
Macedonia, The Former Yugoslav Republic of | |||||
Recruiting | |||||
Skopje, Macedonia, The Former Yugoslav Republic of | |||||
Poland | |||||
Recruiting | |||||
Krakow, Poland | |||||
Recruiting | |||||
Lodz, Poland | |||||
Recruiting | |||||
Gdansk, Poland | |||||
Recruiting | |||||
Oswiecim, Poland | |||||
Recruiting | |||||
Wejherowo, Poland | |||||
Recruiting | |||||
Wroclaw, Poland | |||||
Recruiting | |||||
Poznan, Poland | |||||
Serbia | |||||
Recruiting | |||||
Belgrade, Serbia | |||||
Recruiting | |||||
Nis, Serbia | |||||
Recruiting | |||||
Novisad, Serbia | |||||
South Africa | |||||
Recruiting | |||||
Cape Town, South Africa | |||||
Recruiting | |||||
Gauteng, South Africa | |||||
Spain | |||||
Recruiting | |||||
Oviedo, Spain | |||||
Recruiting | |||||
Barcelona, Spain | |||||
United Kingdom | |||||
Recruiting | |||||
STEVENAGE, United Kingdom |
Mitsubishi Tanabe Pharma Corporation |
Principal Investigator: | Professor | Information at Mitsubishi Pharma Europe |
Responsible Party: | Mitsubishi Tanabe Pharma Corporation ( Study Project Manager ) |
Study ID Numbers: | MCI-196-E09 |
First Received: | March 22, 2007 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00451295 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: State Institute for Drug Control; Italy: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Germany: Federal Institute for Drugs and Medical Devices; South Africa: Medicines Control Council; Spain: Ministry of Health and Consumption |
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