Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
NCT00234871 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 357
Last updated 2008-07-15
Summary
The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy
Conditions
- Hypertension
- Diabetes
- Proteinuria
Interventions
- DRUG
-
trandolapril/verapamil
2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
- DRUG
-
Lotrel (amlodipine/benazepril)
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Medical Information · Abbott
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-01-31
- Primary Completion
- 2005-03-31
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