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

Phase 4

Completed

• Conditions: Hypertension; Diabetes
• Interventions: Drug: trandolapril/verapamil; Drug: placebo; Drug: trandolapril; Drug: verapamil

• Registration Number: NCT00235014
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Primary Completion: 2006-01
• Status Verified: 2008-06
• Last Update Submitted: 2008-07-11
• Last Update Posted: 2008-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1204

Inclusion Criteria

• Type 2 Diabetes
• Hypertension

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-2, B-2	trandolapril/verapamil	A2 pertains to Phase 1; B-2 pertains to Phase 2
A-3	placebo	-
A-1, B-1	trandolapril	A-1 pertains to Phase 1; B-1 pertains to Phase 2
A-4	verapamil	-

Primary Outcome Measures

Name	Time	Method
Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria.	3 years

Secondary Outcome Measures

Name	Time	Method
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