NCT00234871

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypertension
• Diabetes
• Proteinuria

Interventions

Type	Name	Description
DRUG	trandolapril/verapamil	2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
DRUG	Lotrel (amlodipine/benazepril)	5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD

Timeline

• Start date: 2004-01-01
• Primary completion: 2005-03-01
• First posted: 2005-10-10
• Last updated: 2008-07-15