NCT00235014

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,204

participants targeted

Target at P75+ for phase_4 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

July 15, 2008

Status Verified

June 1, 2008

Enrollment Period

8.8 years

First QC Date

September 13, 2005

Last Update Submit

July 11, 2008

Conditions

HypertensionDiabetes

Keywords

hypertensiondiabetestrandolaprilverapamilalbuminuria

Outcome Measures

Primary Outcomes (1)

  • Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria.

    3 years

Secondary Outcomes (1)

  • 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

Study Arms (4)

A-1, B-1

ACTIVE COMPARATOR

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

Drug: trandolapril

A-2, B-2

ACTIVE COMPARATOR

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

Drug: trandolapril/verapamil

A-3

PLACEBO COMPARATOR
Drug: placebo

A-4

ACTIVE COMPARATOR
Drug: verapamil

Interventions

trandolaprilDRUG

2 mg QD

Also known as: ABT-878, Mavik/Gopten
A-1, B-1
trandolapril/verapamilDRUG

180/2 mg QD

Also known as: ABT-TARKA, VeraTran, Tarka
A-2, B-2
placeboDRUG

1 tablet QD

A-3
verapamilDRUG

SR 240 mg QD

Also known as: ABT-150
A-4

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes
  • Hypertension

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 23733198DERIVED

  • 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.

    PMID: 22773704DERIVED

  • 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.

    PMID: 21243736DERIVED

  • 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.

    PMID: 18443191DERIVED

MeSH Terms

Conditions

HypertensionDiabetes MellitusAlbuminuria

Interventions

trandolaprilVerapamilsabadilla

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Global Medical Information 1-800-633-9110

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 10, 2005

Study Start

March 1, 1997

Primary Completion

January 1, 2006

Last Updated

July 15, 2008

Record last verified: 2008-06