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Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

NCT ID: NCT00311870

Last Updated: 2006-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-03-31

Study Completion Date

1999-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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nisoldipine

Intervention Type DRUG

lisinopril

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria

* child bearing potential, non-diabetic kidney disease, malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Peter Rossing, MD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Hans-Henrik Parving, MD

Role: STUDY_CHAIR

Steno Diabetes Center Copenhagen

Locations

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Steno Diabetes Center

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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. doi: 10.2337/diacare.23.12.1725.

Reference Type RESULT
PMID: 11128341 (View on PubMed)

Other Identifiers

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KA 92126

Identifier Type: -

Identifier Source: org_study_id