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
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Condition or disease | Intervention/treatment | Phase |
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Diabetic Kidney Disease | Drug: High dose ACE-I vs ARB | Not Applicable |
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 |

- reducing proteinuria
- glomerular filtration rate
- side-effects of hypotension, postural symptom

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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 |
Inclusion Criteria:
- 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
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Currently taking an angiotensin converting enzyme inhibitor
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Exclusion Criteria:
- 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
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Currently taking an angiotensin receptor antagonist
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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
Canada, Ontario | |
The Ottawa Hospital | |
Ottawa, Ontario, Canada, K1H 7W9 |
Principal Investigator: | Ayub Akbari, MD | OHRI |
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 |
Diabetes Proteinuria Angiotensin converting enzyme inhibitors Angiotensin receptor antagonists |
Kidney Diseases Diabetic Nephropathies Urologic Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |