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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Amlodipine; Benazepril; Trandolapril; Verapamil

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.