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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00234871
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 15, 2008
Sponsor:
Information provided by:
Abbott

Study Description
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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

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Proteinuria Drug: trandolapril/verapamil Drug: Lotrel (amlodipine/benazepril) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2004
Actual Primary Completion Date : March 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Active Comparator: 2 Drug: Lotrel (amlodipine/benazepril)
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD


Outcome Measures
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Primary Outcome Measures :
  1. Changes in urinary albumin:creatinine ratio [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234871


Sponsors and Collaborators
Abbott
Investigators
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Study Director: Global Medical Information Abbott
More Information
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Responsible Party: Peter Bacher, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00234871    
Other Study ID Numbers: M03-599
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: July 15, 2008
Last Verified: July 2008
Keywords provided by Abbott:
Hypertension
Diabetes
Proteinuria
Tarka
Lotrel
Additional relevant MeSH terms:
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Proteinuria
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Urological Manifestations
Verapamil
Amlodipine
 Benazepril
Trandolapril
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors