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

July 11, 2008 updated by: Abbott

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: Lotrel (amlodipine/benazepril)
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD
Active Comparator: 1
Drug: trandolapril/verapamil
2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
Other Names:
  • ABT-TARKA
  • Tarka

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in urinary albumin:creatinine ratio
Time Frame: 36 weeks
36 weeks

Secondary Outcome Measures

Outcome 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.
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Global Medical Information, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

July 15, 2008

Last Update Submitted That Met QC Criteria

July 11, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M03-599

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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