Clinical Trial Details
| Trial ID: | L5731 |
| Source ID: | NCT00503152 |
| Associated Drug: | Benazepril |
| Title: | Preventing Microalbuminuria in Type 2 Diabetes |
| Acronym: | VARIETY |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes |
| Interventions: | DRUG: Benazepril|DRUG: Valsartan|DRUG: Benazepril/Valsartan |
| Outcome Measures: | Primary: Development of persistent microalbuminuria (i.e. urinary albumin excretion rate >20 µg/min in at least 2 of 3 consecutive overnight urine collections confirmed in two consecutive visits). Whenever a patient will be found to have 2 of 3 collections in the, 2 times a year | Secondary: Regression to low-normal albuminuria (i.e. urinary albumin excretion rate <7 µg/min in at least 2 of 3 consecutive overnight urine collections confirmed in two consecutive visits); Albuminuria (considered as a continuous variable); Serum creatinine (v, 2 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: | 612 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2007-05 |
| Completion Date: | 2016-09 |
| Results First Posted: | |
| Last Update Posted: | 2019-09-06 |
| Locations: | Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" - Diabetologic Ambulatory of Ponte San Pietro, Ponte San Pietro, Bergamo, Italy|Clinical Research Center for Rare Diseases "Aldo e Cele Daccò", Ranica, Bergamo, Italy|Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Unit of Diabetology and Metabolic Diseases, Romano di Lombardia, Bergamo, Italy|Hospital "Bolognini", Seriate, Bergamo, Italy|Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases, Treviglio, Bergamo, Italy|Hospital "Casa Sollievo della Sofferenza" - Division of Endocrinology, San Giovanni Rotondo, Foggia, Italy|Hospital "Azienda Ospedaliera Ospedali Riuniti di Bergamo" - Unit of Diabetology, Bergamo, Italy|IRCCS San Raffaele - Unit of General Medicine, Milano, Italy|Azienda USL 2, Olbia, Italy |
| URL: | https://clinicaltrials.gov/show/NCT00503152 |
