A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)
- Conditions
- HypertensionDiabetic Nephropathies
- Registration Number
- NCT00168857
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 860
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample). Up to 1 year
- Secondary Outcome Measures
Name Time Method 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. Up to 1 year
Trial Locations
- Locations (65)
Boehringer Ingelheim Investigational Site
🇳🇿Auckland, New Zealand
VA of Greater Los Angeles
🇺🇸Los Angeles, California, United States
UCI Medical Center
🇺🇸Orange, California, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
UCLA Medical Center
🇺🇸Sylmar, California, United States
Torrance Clinical Research
🇺🇸Torrance, California, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Rush Presbyterian - St. Lukes Medical Center
🇺🇸Chicago, Illinois, United States
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