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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234871
First received: September 13, 2005
Last updated: July 11, 2008
Last verified: July 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Changes in urinary albumin:creatinine ratio [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 357
Study Start Date: January 2004
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • trandolapril/verapamil
  • Tarka
Active Comparator: 2 Drug: Lotrel (amlodipine/benazepril)
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234871

Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information Abbott
  More Information

No publications provided

Responsible Party: Peter Bacher, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00234871     History of Changes
Other Study ID Numbers: M03-599
Study First Received: September 13, 2005
Last Updated: July 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Hypertension
Diabetes
Proteinuria
Tarka
Lotrel

Additional relevant MeSH terms:
Hypertension
Proteinuria
Cardiovascular Diseases
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Vascular Diseases
Benazepril
Trandolapril
Verapamil
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014