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

A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00235014

Acronym

BENEDICT

Enrollment

1204

Registered

2005-10-10

Start date

1997-03-31

Completion date

Unknown

Last updated

2008-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Diabetes

Keywords

hypertension, diabetes, trandolapril, verapamil, albuminuria

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.

Interventions

DRUGtrandolapril

2 mg QD

DRUGtrandolapril/verapamil

180/2 mg QD

DRUGplacebo

1 tablet QD

DRUGverapamil

SR 240 mg QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria.	3 years

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026