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Completed

NCT Number: NCT00235014

A Study for Prevention of Kidney Disease in Diabetic Patients (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.

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Key information

Conditions

Hypertension Albuminuria Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes
  • Hypertension

Exclusion criteria

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

Treatment and study plan

trandolapril

Drug

2 mg QD

Other names: ABT-878, Mavik/Gopten

trandolapril/verapamil

Drug

180/2 mg QD

Other names: ABT-TARKA, VeraTran, Tarka

Placebo

Drug

1 tablet QD

Verapamil

Drug

SR 240 mg QD

Other names: ABT-150

Primary outcomes

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

    Time frame: 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.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Acronym: BENEDICT

Important dates

Study start
1997
Primary completion
2006
First posted
Oct 10, 2005
Registry last updated
Jul 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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