High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy
This study has been completed.
Sponsor:
Ottawa Hospital Research Institute
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Further study details as provided by Ottawa Hospital Research Institute:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
-
Currently taking an angiotensin converting enzyme inhibitor
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
-
Currently taking an angiotensin receptor antagonist
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212901
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
| 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:
|
Kidney Diseases Diabetic Nephropathies Urologic Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Angiotensin-Converting Enzyme Inhibitors Angiotensin Receptor Antagonists Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016