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| Sponsor: | Mario Negri Institute for Pharmacological Research |
|---|---|
| Collaborator: |
Agenzia Italiana del Farmaco |
| Information provided by: | Mario Negri Institute for Pharmacological Research |
| ClinicalTrials.gov Identifier: | NCT00494715 |
Purpose
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 spot morning urine albumin to creatinine ratio >1000mg/g for the patients without previous ACE inhibitor and ARB therapy and >500mg/g for the patients with previous ACE inhibitor or ARB therapy and no specific contraindications to the study drugs. The relationships between renal and cardiovascular outcomes will also be evaluated.
102 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 inhibitor 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: | 102 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Benazepril: Experimental |
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).
|
| valsartan: Experimental |
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).
|
| benazepril/valsartan: Experimental |
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).
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: giuseppe remuzzi, MD | 0039 035 319888 | gremuzzi@marionegri.it |
| Italy | |
| 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 | |
| Principal Investigator: Antonio Bossi, MD | |
| Sub-Investigator: Aneliya Parvanova, MD | |
| 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 | |
| Principal Investigator: Antonio Bossi, MD | |
| Sub-Investigator: Ilian Iliev, MD | |
| 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 | |
| Principal Investigator: Antonio Belviso, MD | |
| Hospital "Azienda Ospedaliera Ospedali Riuniti di Bergamo" - Unit of Diabetology | Recruiting |
| Bergamo, Italy | |
| Contact: Roberto Trevisan, MD 0039 035 266968 rtrevisan@ospedaliriuniti.bergamo.it | |
| Principal Investigator: Roberto Trevisan, MD | |
| Sub-Investigator: Elena Mondo, MD | |
| Hospital "Azienda Ospedaliera di Parma" - Unit of Nephrology | Not yet recruiting |
| Parma, Italy | |
| Contact: Salvatore David, MD 0039 0521 293561 davidren@unipr.it | |
| Principal Investigator: Salvatore David, MD | |
| University - AUSL 1 - Institute of Medical Pathology | Recruiting |
| Sassari, Italy | |
| Contact: Andrea Satta, MD 0039 079 228442 amesatta@uniss.it | |
| Principal Investigator: Andrea Satta, MD | |
| Sub-Investigator: Giovanna Farre, MD | |
| 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 | |
| Principal Investigator: Emanuele Bosi, MD | |
| Hospital "Vittorio Emanuele-Ferrarotto-Santo Bambino" | Not yet recruiting |
| Catania, Italy | |
| Contact: Antonio Granata, MD antonio.granata4@tin.it | |
| Principal Investigator: Antonio Granata, MD | |
| University "Federico II" | Recruiting |
| Napoli, Italy | |
| Contact: Antonio Pisani, MD antonio.pisani@libero.it | |
| Principal Investigator: Antonio Pisani, MD | |
| Sub-Investigator: Gennaro Argentino, MD | |
| Hospital "G:Mazzini" | Recruiting |
| Teramo, Italy | |
| Contact: Goffredo Del Rosso, MD goffredo.delrosso@aslteramo.it | |
| Principal Investigator: Goffredo Del Rosso, MD | |
| Sub-Investigator: Patrizia Santarelli, MD | |
| Italy, Bergamo | |
| Clinical Research Center for Rare Diseases "Aldo e Cele Daccò" | Recruiting |
| Ranica, Bergamo, Italy | |
| Contact: Stefano Rota, MD 0039 035 4535321 | |
| Sub-Investigator: Stefano Rota, MD | |
| Hospital "Bolognini" | Not yet recruiting |
| Seriate, Bergamo, Italy | |
| Principal Investigator: Ruggero Mangili, MD | |
| Italy, Catania | |
| Hospital "S.Marta e S.Venera" | Recruiting |
| Acireale, Catania, Italy | |
| Contact: Maurizio Garozzo, MD mauriziocom@hotmail.com | |
| Principal Investigator: Giovanni Battaglia, MD | |
| Sub-Investigator: Maurizio Garozzo, MD | |
| Italy, Foggia | |
| Hospital " Casa Sollievo della Sofferenza" - Unit of Nephrology | Recruiting |
| San Giovanni Rotondo, Foggia, Italy | |
| Contact: Filippo Aucella, MD 0039 0882 410367 | |
| Sub-Investigator: Rachele Grifa, MD | |
| Principal Investigator: Filippo Aucella, MD | |
| Study Director: | Giuseppe Remuzzi, MD | Mario Negri Institute for Pharmacological Research |
More Information
| Responsible Party: | Mario Negri Institute for Pharmacological Research ( Giuseppe Remuzzi ) |
| Study ID Numbers: | VALID |
| Study First Received: | June 29, 2007 |
| Last Updated: | September 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00494715 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
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 |