Telmisartan vs. Losartan for Improvement of Renal Function in Hypertensive Diabetic Patients With Overt Nephropathy.

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).

Official Title

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

Hypertension, Diabetic Nephropathies

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Further Details

Primary Outcome Measures:

• Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample).

Secondary Outcome 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.

Study Start

July 2003; Study completion: February 2007

Eligibility & Criteria

Ages Eligible for Study: 21 Years – 80 Years, Genders Eligible for Study: Both

Total Enrolment

856

Contact Details

Boehringer Australian information

• Boehringer Ingelheim Investigational Site, Kippa-Ring, Queensland, Australia
• Lyell McEwin Hospital Department of medicine, Elizabeth, South Australia, Australia
• Boehringer Ingelheim Investigational Site, Melbourne, Victoria, Australia
• Geelong Clinical Research Centre, Geelong, Victoria, Australia

Contact Boehringer Ingelheim (international site)