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

Abbott357 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

357

Conditions

Hypertension Diabetes Proteinuria

Interventions

trandolapril/verapamilDRUG

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

Lotrel (amlodipine/benazepril)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Changes in urinary albumin:creatinine ratio

Time frame: 36 weeks

Secondary Outcomes

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.

Time frame: 36 weeks

Data from ClinicalTrials.gov

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