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

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

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

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

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

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