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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

July 11, 2008

Start Date ^†

March 1997

Current Primary Outcome Measures ^†

Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00235014 on ClinicalTrials.gov Archive Site

Current 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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hypertension
Diabetes

Intervention ^†

Drug: trandolapril
Drug: trandolapril/verapamil
Drug: placebo
Drug: verapamil

Study Arms / Comparison Groups

Active Comparator: A-1 pertains to Phase 1; B-1 pertains to Phase 2
Active Comparator: A2 pertains to Phase 1; B-2 pertains to Phase 2

Publications *

Ruggenenti P, Iliev I, Costa GM, Parvanova A, Perna A, Giuliano GA, Motterlini N, Ene-Iordache B, Remuzzi G; Bergamo Nephrologic Diabetes Complications Trial Study Group. Preventing left ventricular hypertrophy by ACE inhibition in hypertensive patients with type 2 diabetes: a prespecified analysis of the Bergamo Nephrologic Diabetes Complications Trial (BENEDICT). Diabetes Care. 2008 Aug;31(8):1629-34. Epub 2008 Apr 28.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

1204

Completion Date

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Type 2 Diabetes
Hypertension

Exclusion Criteria:

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00235014

Responsible Party

Udo Legler, MD, Abbott

Secondary IDs ^††

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Study Director:

Global Medical Information 1-800-633-9110

Abbott

Information Provided By

Abbott

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.