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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: | NCT00494715 |
Nephropathy of type 2 diabetes is the leading cause of end stage renal disease (ESRD) world-wide and is associated with a dramatic excess cardiovascular morbidity and mortality. Two randomized trials found that angiotensin II receptor blockers (ARBs) reduce the incidence of ESRD by about 30%, but have no appreciable effects on cardiovascular mortality. Available data suggest that ACE inhibitors might be similarly renoprotective and even more cardioprotective, but large scale trials on ACE inhibitors, alone or combined with ARBs, in overt nephropathy of type 2 diabetes are missing.
This study will compare the effects, at comparable blood pressure control (systolic/diastolic <130/80 mmHg), of dual renin-angiotensin-system (RAS) blockade by half dose of benazepril and valsartan combination therapy as compared to single RAS blockade by benazepril or valsartan alone at full dose, 20 mg and 160 mg respectively, on ESRD and cardiovascular events in high-risk patients with type 2 diabetes and overt nephropathy, defined as serum creatinine >1.8 mg/dl and < 3.2 mg/dl and urine spot A/C > 2000 mg/g. The relationships between renal and cardiovascular outcomes will also be evaluated.
120 patients will be treated for at least 3 years. At comparable blood pressure control, the study is expected to show a more effective reduction in ESRD and cardiovascular events with combined than with single drug ACE inhibitor or ARB therapy. As compared to ARB, ACE inibitor therapy is expected to have a similar effect on ESRD, but a superior cardioprotective effect. Applied to clinical practice, the findings should help reducing 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 ACEI BEN and ARB VAL Reduces Progression to ESRD More Effectively Than BEN or VAL Alone in High Risk Patients With Type 2 Diabetes and Overt Nephropathy |
Estimated Enrollment: | 120 |
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: giuseppe remuzzi, MD | 0039 035 319888 | gremuzzi@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 | |
Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases | Recruiting |
Treviglio, Italy | |
Contact: Antonio Bossi, MD 0039 0363 4241 antonio_bossi@ospedale.treviglio.bg.it | |
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Unit of Diabetology and Metabolic Diseases | Not yet recruiting |
Romano di Lombardia, Italy | |
Contact: Antonio Bossi, MD 0039 0363 4241 antonio_bossi@ospedale.treviglio.bg.it | |
Hospital "Azienda Ospedaliera Ospedali Riuniti di Bergamo" - Unit of Nephrology | Recruiting |
Bergamo, Italy | |
Contact: Giuseppe Remuzzi, MD 0039 035 269296 gremuzzi@ospedaliriuniti.bergamo.it | |
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" - Ambulatory of Ponte San Pietro | Not yet recruiting |
Ponte San Pietro, Italy | |
Contact: Antonio Belviso, MD 0039 035 603449 belvisoa@tiscali.it | |
IRCCS San Raffaele - Unit of General Medicine | Not yet recruiting |
Milan, Italy | |
Contact: Emanuele Bosi, MD 0039 02 26431 bosi.emanuele@hsr.it | |
Sub-Investigator: Gianpaolo Zerbini, MD | |
Hospital "Azienda Ospedaliera di Parma" - Unit of Nephrology | Not yet recruiting |
Parma, Italy | |
Contact: Salvatore David, MD 0039 0521 293561 davidren@unipr.it | |
University - AUSL 1 - Institute of Medical Pathology | Not yet recruiting |
Sassari, Italy | |
Contact: Andrea Satta, MD 0039 079 228442 amesatta@uniss.it | |
Italy, Bergamo | |
Clinical Research Center for Rare Diseases "Aldo e Cele Daccò" | Recruiting |
Ranica, Bergamo, Italy | |
Contact: Stefano Rota, MD 0039 035 4535321 | |
Italy, Foggia | |
Hospital " Casa Sollievo della Sofferenza" - Unit of Nephrology | Not yet recruiting |
San Giovanni Rotondo, Foggia, Italy | |
Contact: Carmine Stallone, MD 0039 0882 410367 | |
Sub-Investigator: Rachele Grifa, MD | |
Hospital "Casa Solievo 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: | Giuseppe Remuzzi, MD | Mario Negri Institute for Pharmacological Research |
Study ID Numbers: | VALID |
Study First Received: | June 29, 2007 |
Last Updated: | June 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00494715 |
Health Authority: | Italy: Ministry of Health |
Metabolic Diseases Diabetes Mellitus, Type 2 Benazepril Disease Progression Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Kidney Diseases Metabolic disorder Glucose Metabolism Disorders Valsartan |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |