Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00235014
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 15, 2008
Sponsor:
Information provided by:
Abbott

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : March 1997
Actual Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
  • 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
  • VeraTran
  • Tarka
Placebo Comparator: A-3 Drug: placebo
1 tablet QD
Active Comparator: A-4 Drug: verapamil
SR 240 mg QD
Other Name: ABT-150


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235014


Sponsors and Collaborators
Abbott
Investigators
Layout table for investigator information
Study Director: Global Medical Information 1-800-633-9110 Abbott
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Udo Legler, MD, Abbott
ClinicalTrials.gov Identifier: NCT00235014    
Other Study ID Numbers: VeraTran 083
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: July 15, 2008
Last Verified: June 2008
Keywords provided by Abbott:
hypertension
diabetes
trandolapril
verapamil
albuminuria
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Verapamil
Trandolapril
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antihypertensive Agents