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High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy

This study has been completed.
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00212901
First received: September 13, 2005
Last updated: July 25, 2007
Last verified: July 2007
History of Changes
  Purpose

Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.


Condition Intervention
Diabetic Kidney Disease
 Drug: High dose ACE-I vs ARB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • reducing proteinuria

Secondary Outcome Measures:
  • glomerular filtration rate
  • side-effects of hypotension, postural symptom

Estimated Enrollment: 30
Study Start Date: August 2004
Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR>50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
  2. Controlled blood pressure (<150/<90)
  3. Able to give informed consent
  4. Between the ages of 18 and 75
  5. Must be capable of providing a 24 hour urine collection
  6. Negative BHcG test for ruling out pregnancy in women of childbearing age

  7. Currently taking an angiotensin converting enzyme inhibitor

    -

Exclusion Criteria:

  1. Creatinine clearance <50ml/min or 24hour protein excretion >3gm/d.
  2. Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp <100mmHg.
  3. Serum potassium >5.5 on two separate occasions in the previous six months
  4. Previous adverse reaction to angiotensin receptor antagonist medication
  5. Use of NSAIDS including COX2 inhibitors
  6. Pregnant or nursing women will be excluded

  7. Currently taking an angiotensin receptor antagonist

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212901

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Ayub Akbari, MD OHRI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00212901     History of Changes
Other Study ID Numbers: 2004482-01
Study First Received: September 13, 2005
Last Updated: July 25, 2007
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
Diabetes
Proteinuria
Angiotensin converting enzyme inhibitors
Angiotensin receptor antagonists

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Proteinuria
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urination Disorders
 Urological Manifestations
Signs and Symptoms
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013