Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5591
Source ID: NCT00494715
Associated Drug: Benazepril
Title: Preventing ESRD in Overt Nephropathy of Type 2 Diabetes
Acronym: VALID
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes
Interventions: DRUG: Benazepril|DRUG: Valsartan|DRUG: Benazepril/Valsartan
Outcome Measures: Primary: Progression to ESRD (i.e. need for renal replacement therapy by chronic dialysis or renal transplantation), 4 times a year | Secondary: Doubling of serum creatinine (versus baseline), Rate of GFR decline, Incidence of fatal and non-fatal cardiovascular events (stroke, acute myocardial infarction, sudden death), Albumin to creatinine ratio and 24-hour urinary protein excretion., 4 times a year
Sponsor/Collaborators: Sponsor: Mario Negri Institute for Pharmacological Research | Collaborators: Agenzia Italiana del Farmaco
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 102
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-05
Completion Date: 2016-04
Results First Posted:
Last Update Posted: 2016-06-01
Locations: Clinical Research Center for Rare Diseases "Aldo e Cele Daccò", Ranica, Bergamo, Italy|Hospital "Bolognini", Seriate, Bergamo, Italy|Hospital "S.Marta e S.Venera", Acireale, Catania, Italy|Hospital " Casa Sollievo della Sofferenza" - Unit of Nephrology, San Giovanni Rotondo, Foggia, Italy|Hospital "Azienda Ospedaliera Ospedali Riuniti di Bergamo" - Unit of Diabetology, Bergamo, Italy|Hospital "Vittorio Emanuele-Ferrarotto-Santo Bambino", Catania, Italy|IRCCS San Raffaele - Unit of General Medicine, Milan, Italy|University "Federico II", Napoli, Italy|Hospital "Azienda Ospedaliera di Parma" - Unit of Nephrology, Parma, Italy|Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" - Ambulatory of Ponte San Pietro, Ponte San Pietro, Italy|Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Unit of Diabetology and Metabolic Diseases, Romano di Lombardia, Italy|University - AUSL 1 - Institute of Medical Pathology, Sassari, Italy|Hospital "G:Mazzini", Teramo, Italy|Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases, Treviglio, Italy|Clinical Department of Endocrinology, Diabetes and Metabolic Diseases University Medical Centre Ljubljana, Ljubljana, 1000, Slovenia
URL: https://clinicaltrials.gov/show/NCT00494715