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:	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)

Resource links provided by NLM:

MedlinePlus related topics: Calcium Diabetes 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
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

No publications provided by Abbott

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Abbott:

hypertension
diabetes
trandolapril
verapamil
albuminuria

Additional relevant MeSH terms:

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

Membrane Transport Modulators
Trandolapril
Verapamil
Therapeutic Uses
Diltiazem
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010