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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00235014 |
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 |
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Hypertension Diabetes |
Drug: trandolapril Drug: trandolapril/verapamil Drug: placebo Drug: verapamil |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Two-Phase Study for Primary and Secondary Prevention of Diabetic Nephropathy by Combined ACE Inhibition and Calcium Channel Blockade (BENEDICT) |
Enrollment: | 1204 |
Study Start Date: | March 1997 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A-1, B-1: Active Comparator
A-1 pertains to Phase 1; B-1 pertains to Phase 2
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Drug: trandolapril
2 mg QD
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A-2, B-2: Active Comparator
A2 pertains to Phase 1; B-2 pertains to Phase 2
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Drug: trandolapril/verapamil
180/2 mg QD
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A-3: Placebo Comparator |
Drug: placebo
1 tablet QD
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A-4: Active Comparator |
Drug: verapamil
SR 240 mg QD
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Udo Legler, MD ) |
Study ID Numbers: | VeraTran 083 |
Study First Received: | September 13, 2005 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00235014 |
Health Authority: | Italy: Ministry of Health |
hypertension diabetes trandolapril verapamil albuminuria |
Calcium, Dietary Trandolapril Verapamil Albuminuria Diabetic Nephropathies Diltiazem |
Vascular Diseases Diabetes Mellitus Neoplasm Metastasis Kidney Diseases Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Membrane Transport Modulators Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Anti-Arrhythmia Agents |