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

Abbott1,204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,204

Conditions

Hypertension Diabetes

Interventions

trandolaprilDRUG

2 mg QD

trandolapril/verapamilDRUG

180/2 mg QD

placeboDRUG

1 tablet QD

verapamil

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 Diabetes * Hypertension Exclusion Criteria: * Albuminuria (Phase A) * Non-diabetic renal disease * Subject has a hypersensitivity to ACE inhibitor, CCB

Outcomes

Primary Outcomes

Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria.

Time frame: 3 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.