Status:
COMPLETED
Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
Lead Sponsor:
Abbott
Conditions:
Hypertension
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 d...
Eligibility Criteria
Inclusion
- Diabetes
- Hypertension
- Albuminuria
Exclusion
- Type 1 DM.
- Subject has severe hepatic dysfunction at Screening as determined by liver function tests:
- Bilirubin \> 2.0 mg/dL.
- ALT and/or AST \> 3 times the upper limit of normal.
- Subject has poorly controlled diabetes, based on HbA1c \> 10% at Screening.
- Subject has non-diabetic renal disease.
- Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00234871
Start Date
January 1 2004
Last Update
July 15 2008
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