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Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00311870
First received: April 4, 2006
Last updated: NA
Last verified: April 1999
History: No changes posted
  Purpose

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


Condition Intervention Phase
Diabetic Nephropathy
 Drug: nisoldipine
Drug: lisinopril
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • change in glomerular filtration rate from study start to study end

Secondary Outcome Measures:
  • blood pressure response
  • change in urinary albumin excretion rate

Estimated Enrollment: 52
Study Start Date: March 1993
Estimated Study Completion Date: April 1999
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria:

  • child bearing potential, non-diabetic kidney disease, malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311870

Locations
Denmark
Steno Diabetes Center
Gentofte, Denmark, DK-2820
Sponsors and Collaborators
Steno Diabetes Center
Bayer
Investigators
Principal Investigator: Peter Rossing, MD Steno Diabetes Center
Study Chair: Hans-Henrik Parving, MD Steno Diabetes Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00311870     History of Changes
Other Study ID Numbers: KA 92126
Study First Received: April 4, 2006
Last Updated: April 4, 2006
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nisoldipine
Lisinopril
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013