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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235014
First Posted: October 10, 2005
Last Update Posted: July 15, 2008
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.
Information provided by:
Abbott
  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
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)

Resource links provided by NLM:


Further study details as provided by Abbott:

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

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 ]

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
  • 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

  Eligibility

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.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
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
Study Director: Global Medical Information 1-800-633-9110 Abbott
  More Information

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
First Submitted: September 13, 2005
First Posted: October 10, 2005
Last Update Posted: July 15, 2008
Last Verified: June 2008

Keywords provided by Abbott:
hypertension
diabetes
trandolapril
verapamil
albuminuria

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Verapamil
Trandolapril
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antihypertensive Agents