Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)

Study Identifier
M03-599
CT.gov Identifier
NCT00234871
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Hypertension & Blood Pressure
  • Diabetes
  • Kidney Disease
    • Study Drug
  • trandolapril/verapamil
  • Lotrel (amlodipine/benazepril)
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Diabetes - Hypertension - Albuminuria
    Exclusion Criteria:
    - 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.

    Protocol 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

    Study Locations

    No locations found.