| Trial ID: | L7266 |
| Source ID: | NCT00949351
|
| Associated Drug: |
Aliskiren 300mg/D
|
| Title: |
Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes With Nephropathy
|
| Interventions: |
DRUG: Aliskiren 300mg/d
|
| Outcome Measures: |
Primary: Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy, 12 wk after randomization | Secondary: Reduction of systolic blood pressure, 12 wk after randomization|Reduction of proteinuria, 12 wk after randomization|Change in GFR/mo, 12 wk after randomization|Change of Serum prorenin level compare to baseline, 12 wk after randomization|Change of Urinary TGFb1 compare to baseline, 12 wk after randomization
|
| Sponsor/Collaborators: |
Sponsor: Lerdsin General Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-09
|
| Completion Date: |
2010-09
|
| Results First Posted: |
|
| Last Update Posted: |
2009-07-30
|
| Locations: |
Lerdsin General Hospital, Bangkok, 10500, Thailand
|
| URL: |
https://clinicaltrials.gov/show/NCT00949351
|
