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

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Abbott

Status and phase

Completed
Phase 4

Conditions

Hypertension
Diabetes
Proteinuria

Treatments

Drug: trandolapril/verapamil
Drug: Lotrel (amlodipine/benazepril)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00234871
M03-599

Details and patient eligibility

About

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

Enrollment

357 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

357 participants in 2 patient groups

1
Active Comparator group
Treatment:
Drug: trandolapril/verapamil
2
Active Comparator group
Treatment:
Drug: Lotrel (amlodipine/benazepril)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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