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NCT00311870 Clinical Trial

Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311870
Other study ID # KA 92126
Secondary ID
Status Completed
Phase Phase 4
First received April 4, 2006
Last updated April 4, 2006
Start date March 1993
Est. completion date April 1999

Study information
Verified date April 1999
Source Steno Diabetes Center
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date April 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria:

- child bearing potential, non-diabetic kidney disease, malignancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• nisoldipine

• lisinopril

Locations
Country Name City State
Denmark Steno Diabetes Center Gentofte

Sponsors (2)
Lead Sponsor Collaborator
Steno Diabetes Center Bayer

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Tarnow L, Rossing P, Jensen C, Hansen BV, Parving HH. Long-term renoprotective effect of nisoldipine and lisinopril in type 1 diabetic patients with diabetic nephropathy. Diabetes Care. 2000 Dec;23(12):1725-30. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary change in glomerular filtration rate from study start to study end
Secondary blood pressure response
Secondary change in urinary albumin excretion rate
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