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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Diabetes; Proteinuria

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

Phase: Phase 4

Status: Completed

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

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


Inclusion Criteria:

- Diabetes

- Hypertension

- Albuminuria

Exclusion Criteria:

- Type 1 DM.

- Subject has severe hepatic dysfunction at Screening as determined by liver function


- 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.

Locations and Contacts

Additional Information

Starting date: January 2004
Last updated: July 11, 2008

Page last updated: August 23, 2015

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