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

Verified by: Abbott, June 2008
First Received: September 13, 2005 | Last Updated: July 11, 2008 | Phase: Phase 4 | Start Date: March 1997
Overall Status: Completed | Estimated Enrollment: 1204
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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...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2006

Intervention(s) in this Clinical Trial

  • Drug: trandolapril
    • 2 mg QD
  • Drug: trandolapril/verapamil
    • 180/2 mg QD
  • Drug: placebo
    • 1 tablet QD
  • Drug: verapamil
    • SR 240 mg QD

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: A-1, B-1
    • A-1 pertains to Phase 1; B-1 pertains to Phase 2
  • Active Comparator: A-2, B-2
    • A2 pertains to Phase 1; B-2 pertains to Phase 2
  • Placebo Comparator: A-3
  • Active Comparator: A-4

Outcome Measures for this Clinical Trial

Primary Measures

  • Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria.
    • Time Frame: 3 years
      Safety Issue?: Yes

Secondary 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
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Type 2 Diabetes
  • Hypertension

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Abbott Industry

Overall Clinical Trial Officials and Contacts

Global Medical Information 1-800-633-9110 Study Director Abbott  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00235014

Study ID Number: VeraTran 083

ClinicalTrials.gov Identifier: NCT00235014

Health Authority: Italy: Ministry of Health

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