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Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00311870
Enrollment
52
Registered
2006-04-06
Start date
1993-03-31
Completion date
1999-04-30
Last updated
2006-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Brief 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

Interventions

DRUGnisoldipine
DRUGlisinopril

Sponsors

Bayer
CollaboratorINDUSTRY
Steno Diabetes Center Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* diabetic nephropathy, type 1 diabetes, hypertension

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
change in glomerular filtration rate from study start to study end

Secondary

MeasureTime frame
blood pressure response
change in urinary albumin excretion rate

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026