Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy
Information source: Steno Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Nephropathy
Intervention: nisoldipine (Drug); lisinopril (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Steno Diabetes Center Official(s) and/or principal investigator(s): Peter Rossing, MD, Principal Investigator, Affiliation: Steno Diabetes Center Hans-Henrik Parving, MD, Study Chair, Affiliation: Steno Diabetes Center
Summary
The aim of the study was to compare the renoprotective effect of a long acting calcium
antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type
1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to
treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure
and urinary excretion of albumin were measured every 6 months
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: change in glomerular filtration rate from study start to study end
Secondary outcome: blood pressure responsechange in urinary albumin excretion rate
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diabetic nephropathy, type 1 diabetes, hypertension
Exclusion Criteria:
- child bearing potential, non-diabetic kidney disease, malignancy
Locations and Contacts
Steno Diabetes Center, Gentofte DK-2820, Denmark
Additional Information
Starting date: March 1993
Last updated: April 4, 2006
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