A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT)

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00235014

Collaborator

(none)

1,204

Enrollment

Arms

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hypertension Diabetes	Drug: trandolapril Drug: trandolapril/verapamil Drug: placebo Drug: verapamil	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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)

Study Start Date :

Mar 1, 1997

Actual Primary Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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 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 VeraTran Tarka
Placebo Comparator: A-3	Drug: placebo 1 tablet QD
Active Comparator: A-4	Drug: verapamil SR 240 mg QD Other Names: ABT-150

Outcome Measures

Primary Outcome Measures

Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. [3 years]

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. [3 years]