Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR)

Verified by: Abbott, June 2008
First Received: September 13, 2005 | Last Updated: July 11, 2008 | Phase: Phase 4 | Start Date: March 2004
Overall Status: Completed | Estimated Enrollment: 280
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The primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic...

Brief Summary

Official Title: “A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Hyzaar® on Glucose Tolerance in Subjects With Metabolic Syndrome”

The primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2006

Intervention(s) in this Clinical Trial

  • Drug: trandolapril/verapamil
    • 2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
  • Drug: (Hyzaar) losartan/hydrochlorothiazide
    • 50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Oral Glucose Tolerance
    • Time Frame: up to 1 year / 52 weeks
      Safety Issue?: Yes

Secondary Measures

  • Changes in blood pressure (BP), pulse rate and BP control. HbA1c, insulin sensitivity, insulin release, albuminuria, lipid profile, AMBP, clinical safety labs and adverse events.
    • Time Frame: up to 1 year / 52 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Metabolic syndrome
  • Fasting blood glucose between 100 mg/dL and 125 mg/dL
  • Hypertension
  • One additional criteria, Exclusion 1

Exclusion Criteria:

  • Subject has a current diagnosis of Type 1 or Type 2 diabetes mellitus.
  • Subject has a hypersensitivity to ACE inhibitor, ARB, CCB, clonidine, methyldopa, hydralazine, or thiazide diuretic medication.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 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/NCT00234858

Study ID Number: M03-598

ClinicalTrials.gov Identifier: NCT00234858

Health Authority: United States: Food and Drug Administration

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