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

Condition(s) targeted: Hypertension; Diabetes; Proteinuria

Intervention: Tarka (trandolapril/verapamil) (Drug); Lotrel (amlodipine/benazepril) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Global Medical Information, Study Director, Affiliation: Abbott

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

Official title: 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Changes in urinary albumin:creatinine ratio

Secondary outcome: Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: January 2004
Last updated: August 30, 2007