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

A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy

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

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.