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)
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|ClinicalTrials.gov Identifier: NCT00168857|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Diabetic Nephropathies||Drug: telmisartan Drug: losartan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||860 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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)|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||June 2006|
- Change from baseline after one year of treatment in proteinuria (ratio of protein to creatinine as measure in spot urine sample).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168857
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|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim|