| Trial ID: | L1381 |
| Source ID: | NCT01818687
|
| Associated Drug: |
Colestilan
|
| Title: |
Safety and Tolerability Study of MCI-196
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Not on Dialysis|Hyperphosphatemia|Paediatric
|
| Interventions: |
DRUG: colestilan
|
| Outcome Measures: |
Primary: Percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan., 17 weeks | Secondary: Incidence of TEAEs of hypercalcaemia and hypocalcaemia, 17 weeks|Laboratory safety assessments, 17 weeks
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
4
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-08
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-05-27
|
| Locations: |
Investigational site, London, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT01818687
|
