Status:
COMPLETED
High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
- Controlled blood pressure (\<150/\<90)
- Able to give informed consent
- Between the ages of 18 and 75
- Must be capable of providing a 24 hour urine collection
- Negative BHcG test for ruling out pregnancy in women of childbearing age
- Currently taking an angiotensin converting enzyme inhibitor
- \-
Exclusion
- Creatinine clearance \<50ml/min or 24hour protein excretion \>3gm/d.
- Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp \<100mmHg.
- Serum potassium \>5.5 on two separate occasions in the previous six months
- Previous adverse reaction to angiotensin receptor antagonist medication
- Use of NSAIDS including COX2 inhibitors
- Pregnant or nursing women will be excluded
- Currently taking an angiotensin receptor antagonist
- \-
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00212901
Start Date
August 1 2004
End Date
September 1 2006
Last Update
July 26 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9