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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00212901
Other study ID # 2004482-01
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated July 25, 2007
Start date August 2004
Est. completion date September 2006

Study information

Verified date July 2007
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label


Intervention

Drug:
High dose ACE-I vs ARB


Locations

Country Name City State
Canada The Ottawa Hospital Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary reducing proteinuria
Secondary glomerular filtration rate
Secondary side-effects of hypotension, postural symptom
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