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

Sponsored by:	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

MedlinePlus related topics: Calcium Diabetes High Blood Pressure

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

U.S. FDA Resources

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

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
A-1, B-1: Active Comparator A-1 pertains to Phase 1; B-1 pertains to Phase 2	Drug: trandolapril 2 mg QD
A-2, B-2: Active Comparator A2 pertains to Phase 1; B-2 pertains to Phase 2	Drug: trandolapril/verapamil 180/2 mg QD
A-3: Placebo Comparator	Drug: placebo 1 tablet QD
A-4: Active Comparator	Drug: verapamil SR 240 mg QD

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

Publications indexed to this study:

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

Keywords provided by Abbott:

hypertension
diabetes
trandolapril
verapamil
albuminuria

Study placed in the following topic categories:

Calcium, Dietary
Trandolapril
Verapamil
Albuminuria
Diabetic Nephropathies
Diltiazem

Vascular Diseases
Diabetes Mellitus
Neoplasm Metastasis
Kidney Diseases
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009