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Sponsored by: |
Mario Negri Institute for Pharmacological Research |
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Information provided by: | Mario Negri Institute for Pharmacological Research |
ClinicalTrials.gov Identifier: | NCT00503152 |
In people with type 2 diabetes, microalbuminuria is a strong, independent risk factor for diabetic nephropathy and cardiovascular morbidity and mortality. ACE inhibitor therapy decreased the risk of microalbuminuria in hypertensive subjects with type 2 diabetes and normoalbuminuria by about 40%. Available data suggest that angiotensin II receptor blockers (ARBs) might have a similar renoprotective effect and that this effect might be increased by combined ACE inhibitor therapy. The study will evaluate the effects, at similar blood pressure control (systolic/diastolic <130/80 mmHg), for a period of three years, of dual renin-angiotensin-system (RAS) blockade by benazepril and valsartan combination therapy as compared to single RAS blockade by benazepril or valsartan alone on microalbuminuria and cardiovascular events in high-risk patients with type 2 diabetes, creatinine <1.5 mg/dl, no evidence of microalbuminuria but at high risk of renal disease, with hypertesion and a urinary albumin excretion between 10 and 19 microgrammi/min. The relationship between albuminuria and cardiovascular outcomes will also be evaluated. The study is expected to show a more effective prevention of microalbuminuria and cardiovascular events with combined than with single drug ACE inhibitor or ARB therapy. As compared to ACE inhibitor, ARB therapy is expected to have a similar effect on microalbuminuria, but an inferior cardioprotective effect. Applied to clinical practice, the findings should help preventing renal and cardiovascular complications, and related treatment costs, of type 2 diabetes.
Condition | Intervention | Phase |
---|---|---|
Diabetes |
Drug: Benazepril Drug: Valsartan Drug: Benazepril/Valsartan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Probe Trial to Evaluate Whether, at Comparable Blood Pressure Control, Combined Therapy With the ACEI Benazepril and the ARB Valsartan, Reduces the Incidence of Microalbuminuria More Effectively Than BEN or VAL Alone in Hypertensive Patients With Type 2 Diabetes and High-Normal Albuminuria |
Estimated Enrollment: | 1233 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2012 |
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: piero ruggenenti, MD | 0039 035 45351 | ruggenenti@marionegri.it |
Italy | |
Hospital "Azienda Ospedaliera Ospedali Riuniti di Bergamo" - Unit of Diabetology | Recruiting |
Bergamo, Italy | |
Contact: Roberto Trevisan, MD 0039 035 266968 rtrevisan@ospedaliriuniti. bergamo.it | |
IRCCS San Raffaele - Unit of General Medicine | Not yet recruiting |
Milano, Italy | |
Contact: emanuele bosi, MD 0039 02 26431 bosi.emanuele@hsr.it | |
Sub-Investigator: Gianpaolo Zerbini, MD | |
Azienda USL 2 | Not yet recruiting |
Olbia, Italy | |
Contact: Giancarlo Tonolo, MD giancarlo.tonolo@aslolbia.it | |
Italy, Bergamo | |
Clinical Research Center for Rare Diseases "Aldo e Cele Daccò" | Recruiting |
Ranica, Bergamo, Italy | |
Contact: Varusca Brusegan, MD 0039 035 4535321 brusegan@marionegri.it | |
Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases | Recruiting |
Treviglio, Bergamo, Italy | |
Contact: antonio bossi, MD 0039 0363 4241 antoniobossi@ospedale.treviglio.bg.it | |
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Unit of Diabetology and Metabolic Diseases | Not yet recruiting |
Romano di Lombardia, Bergamo, Italy | |
Contact: Antonio Bossi, MD 0039 0363 4241 antonio_bossi@ospedale.treviglio.bg.it | |
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" - Diabetologic Ambulatory of Ponte San Pietro | Not yet recruiting |
Ponte San Pietro, Bergamo, Italy | |
Contact: Antonio Belviso, MD 0039 035 603449 belvisoa@tiscali.it | |
Italy, Foggia | |
Hospital "Casa Sollievo della Sofferenza" - Division of Endocrinology | Not yet recruiting |
San Giovanni Rotondo, Foggia, Italy | |
Contact: vincenzo trischitta, MD vincenzo.trischitta@uniroma1.it | |
Sub-Investigator: Salvatore De Cosmo, MD |
Study Director: | Piero Ruggenenti, MD | Mario Negri Institute for Pharmacological Research |
Study ID Numbers: | VARIETY |
Study First Received: | July 17, 2007 |
Last Updated: | July 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00503152 History of Changes |
Health Authority: | Italy: Ministry of Health |
Albuminuria Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Antihypertensive Agents Protease Inhibitors |
Diabetes Mellitus, Type 2 Benazepril Angiotensin-Converting Enzyme Inhibitors Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Valsartan |
Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Therapeutic Uses Diabetes Mellitus, Type 2 Benazepril Angiotensin-Converting Enzyme Inhibitors Glucose Metabolism Disorders Valsartan |