A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT) (BENEDICT)
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ClinicalTrials.gov Identifier: NCT00235014 |
Recruitment Status :
Completed
First Posted : October 10, 2005
Last Update Posted : July 15, 2008
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Condition or disease | Intervention/treatment | Phase |
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Hypertension Diabetes | Drug: trandolapril Drug: trandolapril/verapamil Drug: placebo Drug: verapamil | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A-1, B-1
A-1 pertains to Phase 1; B-1 pertains to Phase 2
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Drug: trandolapril
2 mg QD
Other Names:
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Active Comparator: A-2, B-2
A2 pertains to Phase 1; B-2 pertains to Phase 2
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Drug: trandolapril/verapamil
180/2 mg QD
Other Names:
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Placebo Comparator: A-3 |
Drug: placebo
1 tablet QD |
Active Comparator: A-4 |
Drug: verapamil
SR 240 mg QD
Other Name: ABT-150 |
- Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. [ Time Frame: 3 years ]
- 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 ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 Diabetes
- Hypertension
Exclusion Criteria:
- Albuminuria (Phase A)
- Non-diabetic renal disease
- Subject has a hypersensitivity to ACE inhibitor, CCB

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
Study Director: | Global Medical Information 1-800-633-9110 | Abbott |
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 |
hypertension diabetes trandolapril verapamil albuminuria |
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 |