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

Verified by: Abbott, July 2008
First Received: September 13, 2005 | Last Updated: July 11, 2008 | Phase: Phase 4 | Start Date: January 2004
Overall Status: Completed | Estimated Enrollment: 357
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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...

Brief Summary

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”

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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2005

Intervention(s) in this Clinical Trial

  • Drug: trandolapril/verapamil
    • 2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD
  • Drug: Lotrel (amlodipine/benazepril)
    • 5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Changes in urinary albumin:creatinine ratio
    • Time Frame: 36 weeks
      Safety Issue?: Yes

Secondary 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
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Abbott Industry

Overall Clinical Trial Officials and Contacts

Global Medical Information Study Director Abbott  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234871

Study ID Number: M03-599

ClinicalTrials.gov Identifier: NCT00234871

Health Authority: United States: Food and Drug Administration

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