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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00235014
First received: September 13, 2005
Last updated: July 11, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Diabetes
 Drug: trandolapril
Drug: trandolapril/verapamil
Drug: placebo
Drug: verapamil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1204
Study Start Date: March 1997
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A-1, B-1
A-1 pertains to Phase 1; B-1 pertains to Phase 2
 Drug: trandolapril
2 mg QD
Other Names:
  • ABT-878
  • trandolapril
  • Mavik/Gopten
Active Comparator: A-2, B-2
A2 pertains to Phase 1; B-2 pertains to Phase 2
 Drug: trandolapril/verapamil
180/2 mg QD
Other Names:
  • ABT-TARKA
  • trandolapril/verapamil
  • VeraTran
  • Tarka
Placebo Comparator: A-3 Drug: placebo
1 tablet QD
Other Name: placebo
Active Comparator: A-4 Drug: verapamil
SR 240 mg QD
Other Names:
  • ABT-150
  • verapamil

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes
  • Hypertension

Exclusion Criteria:

  • Albuminuria (Phase A)
  • Non-diabetic renal disease
  • Subject has a hypersensitivity to ACE inhibitor, CCB
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235014

Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information 1-800-633-9110 Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Udo Legler, MD, Abbott
ClinicalTrials.gov Identifier: NCT00235014     History of Changes
Other Study ID Numbers: VeraTran 083
Study First Received: September 13, 2005
Last Updated: July 11, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by Abbott:
hypertension
diabetes
trandolapril
verapamil
albuminuria

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Nephropathies
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases
Verapamil
Diltiazem
 Trandolapril
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013