| Trial ID: | L5418 |
| Source ID: | NCT00143949
|
| Associated Drug: |
Enalapril
|
| Title: |
Renin Angiotensin System Study (RASS/B-RASS)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: enalapril|DRUG: losartan
|
| Outcome Measures: |
Primary: To recruit 285 type 1 DM Pts without HTN, diabetic nephropathy, or microalbuminuria into a 5-year study to determine the effect of inhibition RAS with either losartan or enalapril., 5 year|To obtain two percutaneous renal biopsies from each patient, five years apart., 5 year | Secondary: To evaluate retinal lesions in RASS cohort to determine relationship to the histologic changes of DN and the effects of RAS inhibition and/or systemic blood pressure., 5 year
|
| Sponsor/Collaborators: |
Sponsor: Michael Mauer, MD | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Merck Sharp & Dohme LLC|Merck Frosst Canada Ltd.|Canadian Institutes of Health Research (CIHR)
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
285
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose:
|
| Start Date: |
1997-03
|
| Completion Date: |
2008-05
|
| Results First Posted: |
|
| Last Update Posted: |
2008-11-06
|
| Locations: |
Mt Sinai Hospital, University of Toronto (Clinical Ctr), Toronto, Ontario, M5G 1X5, Canada|Royal Victoria Hospital, McGill University (Data Center), Montreal, Quebec, H3A 1A1, Canada|Montreal Childrens Hospital, McGill University (Clinical Ctr), Montreal, Quebec, H3H 1P3, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00143949
|
