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The BENEDICT study is conducted to examine the effects of an ACE inhibitor, calcium channel blockade, a combination of these, and placebo, in the prevention of micro- and macro-albuminuria in Type 2 diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-1, B-1 | Active Comparator | A-1 pertains to Phase 1; B-1 pertains to Phase 2 |
|
| A-2, B-2 | Active Comparator | A2 pertains to Phase 1; B-2 pertains to Phase 2 |
|
| A-3 | Placebo Comparator |
| |
| A-4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trandolapril | Drug | 2 mg QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Course of albumin excretion over time, GFR, blood pressure (BP), incidence of major CV events, overall and CV mortality, HbA1c, progression of retinal changes. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Medical Information 1-800-633-9110 | Abbott | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23733198 | Derived | Rurali E, Noris M, Chianca A, Donadelli R, Banterla F, Galbusera M, Gherardi G, Gastoldi S, Parvanova A, Iliev I, Bossi A, Haefliger C, Trevisan R, Remuzzi G, Ruggenenti P; BENEDICT Study Group. ADAMTS13 predicts renal and cardiovascular events in type 2 diabetic patients and response to therapy. Diabetes. 2013 Oct;62(10):3599-609. doi: 10.2337/db13-0530. Epub 2013 Jun 3. | |
| 22773704 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C052035 | trandolapril |
| D014700 | Verapamil |
| C442300 | sabadilla |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| trandolapril/verapamil | Drug | 180/2 mg QD |
|
|
| placebo | Drug | 1 tablet QD |
|
| verapamil | Drug | SR 240 mg QD |
|
|
| Derived |
| Ruggenenti P, Porrini EL, Gaspari F, Motterlini N, Cannata A, Carrara F, Cella C, Ferrari S, Stucchi N, Parvanova A, Iliev I, Dodesini AR, Trevisan R, Bossi A, Zaletel J, Remuzzi G; GFR Study Investigators. Glomerular hyperfiltration and renal disease progression in type 2 diabetes. Diabetes Care. 2012 Oct;35(10):2061-8. doi: 10.2337/dc11-2189. Epub 2012 Jul 6. |
| 21243736 | Derived | Ruggenenti P, Fassi A, Ilieva A, Iliev IP, Chiurchiu C, Rubis N, Gherardi G, Ene-Iordache B, Gaspari F, Perna A, Cravedi P, Bossi A, Trevisan R, Motterlini N, Remuzzi G; BENEDICT-B Study Investigators. Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria: the BENEDICT-B randomized trial. J Hypertens. 2011 Feb;29(2):207-16. doi: 10.1097/hjh.0b013e32834069bd. |
| 18443191 | Derived | Ruggenenti P, Iliev I, Costa GM, Parvanova A, Perna A, Giuliano GA, Motterlini N, Ene-Iordache B, Remuzzi G; Bergamo Nephrologic Diabetes Complications Trial Study Group. Preventing left ventricular hypertrophy by ACE inhibition in hypertensive patients with type 2 diabetes: a prespecified analysis of the Bergamo Nephrologic Diabetes Complications Trial (BENEDICT). Diabetes Care. 2008 Aug;31(8):1629-34. doi: 10.2337/dc08-0371. Epub 2008 Apr 28. |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |