| Trial ID: | L3129 |
| Source ID: | NCT02345057
|
| Associated Drug: |
Cs-3150
|
| Title: |
A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetic Nephropathy
|
| Interventions: |
DRUG: CS-3150|DRUG: placebo
|
| Outcome Measures: |
Primary: Change from baseline in urinary albumin to creatine ratio (UACR), Baseline to end of Week 12 | Secondary: Transition from microalbuminuria to normoalbuminuria, Baseline to end of Week 12|Change in renal function, Baseline to end of Week 12|Change in serum potassium, Baseline to end of Week 12
|
| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
365
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-01
|
| Completion Date: |
2016-07
|
| Results First Posted: |
|
| Last Update Posted: |
2018-12-21
|
| Locations: |
Kumamoto, 862-0976, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02345057
|