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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE October 10, 2005
Last Update Posted Date July 15, 2008
Study Start Date  ICMJE March 1997
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT)
Official Title  ICMJE A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Diabetes
Intervention  ICMJE
  • Drug: trandolapril
    2 mg QD
    Other Names:
    • ABT-878
    • Mavik/Gopten
  • Drug: trandolapril/verapamil
    180/2 mg QD
    Other Names:
    • ABT-TARKA
    • VeraTran
    • Tarka
  • Drug: placebo
    1 tablet QD
  • Drug: verapamil
    SR 240 mg QD
    Other Name: ABT-150
Study Arms  ICMJE
  • Active Comparator: A-1, B-1
    A-1 pertains to Phase 1; B-1 pertains to Phase 2
    Intervention: Drug: trandolapril
  • Active Comparator: A-2, B-2
    A2 pertains to Phase 1; B-2 pertains to Phase 2
    Intervention: Drug: trandolapril/verapamil
  • Placebo Comparator: A-3
    Intervention: Drug: placebo
  • Active Comparator: A-4
    Intervention: Drug: verapamil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2005)
1204
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 Diabetes
  • Hypertension

Exclusion Criteria:

  • Albuminuria (Phase A)
  • Non-diabetic renal disease
  • Subject has a hypersensitivity to ACE inhibitor, CCB
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00235014
Other Study ID Numbers  ICMJE VeraTran 083
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Udo Legler, MD, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Medical Information 1-800-633-9110 Abbott
PRS Account Abbott
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP