A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT) - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00235014

Purpose

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.

Condition	Intervention	Phase
Hypertension Diabetes	Drug: trandolapril Drug: trandolapril/verapamil Drug: placebo Drug: verapamil	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Calcium Diabetic Kidney Problems High Blood Pressure

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Trandolapril Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Course of albumin excretion over time, GFR, blood pressure (BP), incidence of major CV events, overall and CV mortality, HbA1c, progression of retinal changes. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	1204
Study Start Date:	March 1997
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A-1, B-1 A-1 pertains to Phase 1; B-1 pertains to Phase 2	Drug: trandolapril 2 mg QD Other Names: ABT-878 trandolapril Mavik/Gopten
Active Comparator: A-2, B-2 A2 pertains to Phase 1; B-2 pertains to Phase 2	Drug: trandolapril/verapamil 180/2 mg QD Other Names: ABT-TARKA trandolapril/verapamil VeraTran Tarka
Placebo Comparator: A-3	Drug: placebo 1 tablet QD Other Name: placebo
Active Comparator: A-4	Drug: verapamil SR 240 mg QD Other Names: ABT-150 verapamil

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes
Hypertension

Exclusion Criteria:

Albuminuria (Phase A)
Non-diabetic renal disease
Subject has a hypersensitivity to ACE inhibitor, CCB

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235014

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Global Medical Information 1-800-633-9110

Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ruggenenti P, Fassi A, Ilieva AP, 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.

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. Epub 2008 Apr 28.

Responsible Party:	Udo Legler, MD, Abbott
ClinicalTrials.gov Identifier:	NCT00235014 History of Changes
Other Study ID Numbers:	VeraTran 083
Study First Received:	September 13, 2005
Last Updated:	July 11, 2008
Health Authority:	Italy: Ministry of Health

Keywords provided by Abbott:

hypertension
diabetes
trandolapril
verapamil
albuminuria

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetic Nephropathies
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases
Verapamil
Diltiazem

Trandolapril
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012