Preventing Microalbuminuria in Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

612

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

July 31, 2016

Study Completion Date

September 30, 2016

Conditions
Diabetes
Interventions
DRUG

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).

DRUG

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).

DRUG

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).

Trial Locations (9)

Unknown

"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

All Listed Sponsors
collaborator

Agenzia Italiana del Farmaco

OTHER_GOV

lead

Mario Negri Institute for Pharmacological Research

OTHER

NCT00503152 - Preventing Microalbuminuria in Type 2 Diabetes | Biotech Hunter | Biotech Hunter