A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL,...
Date First Received: September 9, 2005
Last Updated: March 6, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, March 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2003
Overall Status: Completed
Estimated Enrollment: 856
Brief Summary
Official Title: “Telmisartan vs. Losartan for Improvement of Renal Function in Hypertensive Diabetic Patients With Overt Nephropathy.”
Condition Keyword(s):
Intervention(s):
A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug.
The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: telmisartan
- Drug: losartan
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample).
Secondary Measures
- Change from baseline after one year of treatment in the following: glomerular filtration rate; serum creatinine; macroalbuminuria; sodium excretion; high sensitive C-reactive protein; serum aldosterone; and other renal and cardiovascular measures.
Criteria for Participation in this Clinical Trial
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Boehringer Ingelheim Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on March 18, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00168857
Study ID Number: 502.397
ClinicalTrials.gov Identifier: NCT00168857
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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