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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: July 11, 2008
Last verified: July 2008
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
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:
  • Tarka
Active Comparator: 2 Drug: Lotrel (amlodipine/benazepril)
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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:

Additional relevant MeSH terms:
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016