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

Abbott

Status and phase: Completed; Phase 4

Conditions: Hypertension; Diabetes

Treatments: Drug: trandolapril; Drug: verapamil; Drug: placebo; Drug: trandolapril/verapamil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00235014

VeraTran 083

Details and patient eligibility

About

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.

Enrollment: 1,204 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes
• Hypertension

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,204 participants in 4 patient groups, including a placebo group

A-1, B-1

Active Comparator group

Description:

A-1 pertains to Phase 1; B-1 pertains to Phase 2

Treatment:

Drug: trandolapril

A-2, B-2

Active Comparator group

Description:

A2 pertains to Phase 1; B-2 pertains to Phase 2

Treatment:

Drug: trandolapril/verapamil

A-3

Placebo Comparator group

Treatment:

Drug: placebo

A-4

Active Comparator group

Treatment:

Drug: verapamil