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

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ClinicalTrials.gov Identifier: NCT00212901
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 26, 2007
Sponsor:
Information provided by:
Ottawa Hospital Research Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: High dose ACE-I vs ARB Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2004
Actual Study Completion Date : September 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. reducing proteinuria

Secondary Outcome Measures :
  1. glomerular filtration rate
  2. side-effects of hypotension, postural symptom

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00212901


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Ayub Akbari, MD OHRI
More Information
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ClinicalTrials.gov Identifier: NCT00212901    
Other Study ID Numbers: 2004482-01
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 26, 2007
Last Verified: July 2007
Keywords provided by Ottawa Hospital Research Institute:
Diabetes
Proteinuria
Angiotensin converting enzyme inhibitors
Angiotensin receptor antagonists
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases