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Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311870
First Posted: April 6, 2006
Last Update Posted: April 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by:
Steno Diabetes Center
  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
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 4, 2006
First Posted: April 6, 2006
Last Update Posted: April 6, 2006
Last Verified: April 1999

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