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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234871

Acronym

TANDEM

Enrollment

357

Registered

2005-10-10

Start date

2004-01-31

Completion date

Unknown

Last updated

2008-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Diabetes, Proteinuria

Keywords

Hypertension, Diabetes, Proteinuria, Tarka, Lotrel

Brief 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

Interventions

DRUGtrandolapril/verapamil

2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD

DRUGLotrel (amlodipine/benazepril)

5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Changes in urinary albumin:creatinine ratio	36 weeks

Secondary

Measure	Time frame
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.	36 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026