NCT00168857

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)

A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare MICARDIS® (Telmisartan) 80 mg Versus COZAAR® (Losartan) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 860 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypertension
• Diabetic Nephropathies

Interventions

Type	Name	Description
DRUG	telmisartan
DRUG	losartan

Timeline

• Start date: 2003-07-09
• Primary completion: 2006-06-01
• First posted: 2005-09-15
• Last updated: 2023-12-08

Locations

109 sites across 10 countries: United States, Argentina, Australia, Brazil, Canada, Mexico, New Zealand, South Korea, Taiwan, Thailand