| Trial ID: | L0821 |
| Source ID: | NCT00451295
|
| Associated Drug: |
Mci-196(Colestilan(Inn), Colestimide(Jan), Cholebine®)
|
| Title: |
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Dialysis|Hyperphosphatemia
|
| Interventions: |
DRUG: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)|DRUG: Placebo
|
| Outcome Measures: |
Primary: Serum phosphorus change compared to placebo from baseline to week 12., 12 weeks | Secondary: Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
6
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-05
|
| Completion Date: |
2011-01
|
| Results First Posted: |
|
| Last Update Posted: |
2011-11-15
|
| Locations: |
Frydek-Mistek, Czech Republic|Ostrava, Czech Republic|Bordeaux, France|Montpelier, France|Aachen, Germany|Coburg, Germany|Lecco, Italy|Milan, Italy|Pavia, Italy|Skopje, Macedonia, The Former Yugoslav Republic of|Gdansk, Poland|Krakow, Poland|Lodz, Poland|Oswiecim, Poland|Poznan, Poland|Wejherowo, Poland|Wroclaw, Poland|Belgrade, Serbia|Nis, Serbia|Novisad, Serbia|Cape Town, South Africa|Gauteng, South Africa|Barcelona, Spain|Oviedo, Spain|Stevenage, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00451295
|
