Preventing ESRD in Overt Nephropathy of Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Diabetes
Interventions
DRUG

Benazepril

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

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

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 (15)

1000

Clinical Department of Endocrinology, Diabetes and Metabolic Diseases University Medical Centre Ljubljana, Ljubljana

Unknown

"Hospital Azienda Ospedaliera Ospedali Riuniti di Bergamo - Unit of Diabetology", Bergamo

"Clinical Research Center for Rare Diseases Aldo e Cele Daccò", Ranica

"Hospital Bolognini", Seriate

"Hospital S.Marta e S.Venera", Acireale

"Hospital Vittorio Emanuele-Ferrarotto-Santo Bambino", Catania

"Hospital Casa Sollievo della Sofferenza - Unit of Nephrology", San Giovanni Rotondo

"University Federico II", Napoli

"Hospital G:Mazzini", Teramo

IRCCS San Raffaele - Unit of General Medicine, Milan

"Hospital Azienda Ospedaliera di Parma - Unit of Nephrology", Parma

"Hospital Azienda Ospedaliera di Treviglio e Caravaggio - Ambulatory of Ponte San Pietro", Ponte San Pietro

"Hospital Azienda Ospedaliera di Treviglio e Caravaggio Unit of Diabetology and Metabolic Diseases", Romano di Lombardia

University - AUSL 1 - Institute of Medical Pathology, Sassari

"Hospital Azienda Ospedaliera di Treviglio-CaravaggioUnit of Diabetology and Metabolic Diseases", Treviglio

All Listed Sponsors
collaborator

Agenzia Italiana del Farmaco

OTHER_GOV

lead

Mario Negri Institute for Pharmacological Research

OTHER

NCT00494715 - Preventing ESRD in Overt Nephropathy of Type 2 Diabetes | Biotech Hunter | Biotech Hunter