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Completed

NCT Number: NCT00311870

Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

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

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Steno Diabetes Center

Gentofte Municipality, DK-2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetic nephropathy, type 1 diabetes, hypertension

Exclusion criteria

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

Treatment and study plan

nisoldipine

Drug

Lisinopril

Drug

Primary outcomes

  1. change in glomerular filtration rate from study start to study end

Secondary outcomes

  1. blood pressure response

  2. change in urinary albumin excretion rate

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • Bayer

Registry information

Important dates

Study start
1993
Study completion
1999
First posted
Apr 6, 2006
Registry last updated
Apr 6, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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