A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT)
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Diabetes
Intervention: trandolapril (Drug); verapamil (Drug); trandolapril/verapamil (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Global Medical Information 1-800-633-9110, Study Director, Affiliation: Abbott
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.
Clinical Details
Official title: A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria.
Secondary outcome: Course of albumin excretion over time, GFR, blood pressure (BP), incidence of major CV events, overall and CV mortality, HbA1c, progression of retinal changes.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 2 Diabetes
- Hypertension
Exclusion Criteria:
- Albuminuria (Phase A)
- Non-diabetic renal disease
- Subject has a hypersensitivity to ACE inhibitor, CCB
Locations and Contacts
Additional Information
Starting date: March 1997
Last updated: August 30, 2007
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