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

July 11, 2008 updated by: Abbott

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1204

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes
  • Hypertension

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A-1, B-1
A-1 pertains to Phase 1; B-1 pertains to Phase 2
Drug: trandolapril
2 mg QD
Other Names:
  • ABT-878
  • Mavik/Gopten
Active Comparator: A-2, B-2
A2 pertains to Phase 1; B-2 pertains to Phase 2
Drug: trandolapril/verapamil
180/2 mg QD
Other Names:
  • ABT-TARKA
  • Tarka
  • VeraTran
Placebo Comparator: A-3
Drug: placebo
1 tablet QD
Active Comparator: A-4
Drug: verapamil
SR 240 mg QD
Other Names:
  • ABT-150

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Primary Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

July 15, 2008

Last Update Submitted That Met QC Criteria

July 11, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VeraTran 083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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