| Trial ID: | L4541 |
| Source ID: | NCT00557518
|
| Associated Drug: |
Alagebrium
|
| Title: |
Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Diabetic Nephropathy
|
| Interventions: |
DRUG: Alagebrium|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline in albumin excretion rate (µg/min), 24 weeks | Secondary: Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Synvista Therapeutics, Inc | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-11
|
| Completion Date: |
2009-11
|
| Results First Posted: |
|
| Last Update Posted: |
2009-01-30
|
| Locations: |
Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia|International Diabetes Institute, Caulfield, Victoria, 3162, Australia|Dept. of Clinical and Biomedical Science Myers House, Geelong, Victoria, 3220, Australia|Austin Health, Heidelburg, Victoria, 3084, Australia|The Alfred Hospital, Melbourne, Victoria, 3004, Australia|Steno Diabetes Center, Gentofte, DK-2820, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT00557518
|
