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

NCT ID: NCT00234871

Last Updated: 2008-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension Diabetes Proteinuria

Keywords

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Hypertension Diabetes Proteinuria Tarka Lotrel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

trandolapril/verapamil

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

Lotrel (amlodipine/benazepril)

Intervention Type DRUG

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

Interventions

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trandolapril/verapamil

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

Intervention Type DRUG

Lotrel (amlodipine/benazepril)

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

Intervention Type DRUG

Other Intervention Names

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ABT-TARKA Tarka

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Global Medical Information

Role: STUDY_DIRECTOR

Abbott

Other Identifiers

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M03-599

Identifier Type: -

Identifier Source: org_study_id