612
Participants
Start Date
May 31, 2007
Primary Completion Date
July 31, 2016
Study Completion Date
September 30, 2016
Benazepril
After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
Valsartan
After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
Benazepril/Valsartan
After one month wash-out from previous RAS (ARB or ACE) inhibitor therapy, patients satisfying the inclusion/exclusion criteria will be randomly given equivalent doses (half the standard doses recommended by the manufacturer for blood pressure control) of benazepril (10 mg/day) or valsartan (160 mg/day) or one fourth of the standard doses of both agents in combination (benazepril 5 mg/day and valsartan 80 mg/day). If well tolerated, treatment will be up-titrated to full dose of benazepril (20 mg/day) or valsartan (320 mg/day) or one half of the standard doses of both agents in combination (benazepril 10 mg/day and valsartan 160 mg/day).
"Hospital Azienda Ospedaliera di Treviglio e Caravaggio - Diabetologic Ambulatory of Ponte San Pietro", Ponte San Pietro
"Clinical Research Center for Rare Diseases Aldo e Cele Daccò", Ranica
"Hospital Azienda Ospedaliera di Treviglio e Caravaggio Unit of Diabetology and Metabolic Diseases", Romano di Lombardia
"Hospital Bolognini", Seriate
"Hospital Azienda Ospedaliera di Treviglio-CaravaggioUnit of Diabetology and Metabolic Diseases", Treviglio
"Hospital Casa Sollievo della Sofferenza - Division of Endocrinology", San Giovanni Rotondo
"Hospital Azienda Ospedaliera Ospedali Riuniti di Bergamo - Unit of Diabetology", Bergamo
IRCCS San Raffaele - Unit of General Medicine, Milan
Azienda USL 2, Olbia
Agenzia Italiana del Farmaco
OTHER_GOV
Mario Negri Institute for Pharmacological Research
OTHER