| Trial ID: | L4557 |
| Source ID: | NCT00202618
|
| Associated Drug: |
Valsartan
|
| Title: |
Rationale and Design for Shiga Microalbuminuria Reduction Trial
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Diabetes Mellitus|Albuminuria
|
| Interventions: |
DRUG: Valsartan|DRUG: Amlodipine
|
| Outcome Measures: |
Primary: A change in the rate of urinary albumin excretion (UAE) from the baseline to the end of study|A normalization of microalbuminuria (normoalbuminuria)|A 50% reduction in UAE from the baseline | Secondary: A change in urinary type IV collagen from the baseline to the end of the intervention period|A change in high sensitivity C-reactive protein (hsCRP) from the baseline to the end of the intervention period
|
| Sponsor/Collaborators: |
Sponsor: Shiga University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
160
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-12
|
| Completion Date: |
2006-06
|
| Results First Posted: |
|
| Last Update Posted: |
2006-04-27
|
| Locations: |
Shiga University of Medical Science, Otsu, Shiga, 520-2192, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00202618
|
