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

NCT ID: NCT00235014

Last Updated: 2008-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1204 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Diabetes

Keywords

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hypertension diabetes trandolapril verapamil albuminuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A-1, B-1

A-1 pertains to Phase 1; B-1 pertains to Phase 2

Group Type ACTIVE_COMPARATOR

trandolapril

Intervention Type DRUG

2 mg QD

A-2, B-2

A2 pertains to Phase 1; B-2 pertains to Phase 2

Group Type ACTIVE_COMPARATOR

trandolapril/verapamil

Intervention Type DRUG

180/2 mg QD

A-3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1 tablet QD

A-4

Group Type ACTIVE_COMPARATOR

verapamil

Intervention Type DRUG

SR 240 mg QD

Interventions

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trandolapril

2 mg QD

Intervention Type DRUG

trandolapril/verapamil

180/2 mg QD

Intervention Type DRUG

placebo

1 tablet QD

Intervention Type DRUG

verapamil

SR 240 mg QD

Intervention Type DRUG

Other Intervention Names

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ABT-878 Mavik/Gopten ABT-TARKA VeraTran Tarka ABT-150

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes
* Hypertension

Exclusion Criteria

* Albuminuria (Phase A)
* Non-diabetic renal disease
* Subject has a hypersensitivity to ACE inhibitor, CCB
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Global Medical Information 1-800-633-9110

Role: STUDY_DIRECTOR

Abbott

References

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Rurali E, Noris M, Chianca A, Donadelli R, Banterla F, Galbusera M, Gherardi G, Gastoldi S, Parvanova A, Iliev I, Bossi A, Haefliger C, Trevisan R, Remuzzi G, Ruggenenti P; BENEDICT Study Group. ADAMTS13 predicts renal and cardiovascular events in type 2 diabetic patients and response to therapy. Diabetes. 2013 Oct;62(10):3599-609. doi: 10.2337/db13-0530. Epub 2013 Jun 3.

Reference Type DERIVED
PMID: 23733198 (View on PubMed)

Ruggenenti P, Porrini EL, Gaspari F, Motterlini N, Cannata A, Carrara F, Cella C, Ferrari S, Stucchi N, Parvanova A, Iliev I, Dodesini AR, Trevisan R, Bossi A, Zaletel J, Remuzzi G; GFR Study Investigators. Glomerular hyperfiltration and renal disease progression in type 2 diabetes. Diabetes Care. 2012 Oct;35(10):2061-8. doi: 10.2337/dc11-2189. Epub 2012 Jul 6.

Reference Type DERIVED
PMID: 22773704 (View on PubMed)

Ruggenenti P, Fassi A, Ilieva A, Iliev IP, Chiurchiu C, Rubis N, Gherardi G, Ene-Iordache B, Gaspari F, Perna A, Cravedi P, Bossi A, Trevisan R, Motterlini N, Remuzzi G; BENEDICT-B Study Investigators. Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria: the BENEDICT-B randomized trial. J Hypertens. 2011 Feb;29(2):207-16. doi: 10.1097/hjh.0b013e32834069bd.

Reference Type DERIVED
PMID: 21243736 (View on PubMed)

Ruggenenti P, Iliev I, Costa GM, Parvanova A, Perna A, Giuliano GA, Motterlini N, Ene-Iordache B, Remuzzi G; Bergamo Nephrologic Diabetes Complications Trial Study Group. Preventing left ventricular hypertrophy by ACE inhibition in hypertensive patients with type 2 diabetes: a prespecified analysis of the Bergamo Nephrologic Diabetes Complications Trial (BENEDICT). Diabetes Care. 2008 Aug;31(8):1629-34. doi: 10.2337/dc08-0371. Epub 2008 Apr 28.

Reference Type DERIVED
PMID: 18443191 (View on PubMed)

Other Identifiers

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VeraTran 083

Identifier Type: -

Identifier Source: org_study_id