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NCT00235014 Clinical Trial

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

Hypertension Clinical Trial

— BENEDICT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00235014
Other study ID # VeraTran 083
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated July 11, 2008
Start date March 1997

Study information
Verified date June 2008
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1204
Est. completion date
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Type 2 Diabetes

- Hypertension

Exclusion Criteria:

- Albuminuria (Phase A)

- Non-diabetic renal disease

- Subject has a hypersensitivity to ACE inhibitor, CCB

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Outcome
Type Measure Description Time frame Safety issue
Primary Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. 3 years Yes
Secondary 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 Yes
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