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

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. Identifier: NCT00234858
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 15, 2008
Information provided by:

September 13, 2005
October 10, 2005
July 15, 2008
March 2004
April 2006   (Final data collection date for primary outcome measure)
Oral Glucose Tolerance [ Time Frame: up to 1 year / 52 weeks ]
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Complete list of historical versions of study NCT00234858 on Archive Site
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 ]
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Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR)
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
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Metabolic Syndrome
  • Drug: trandolapril/verapamil
    2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
    Other Names:
    • Tarka
  • Drug: (Hyzaar) losartan/hydrochlorothiazide
    50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD
    Other Names:
    • Hyzaar
    • losartan/hydrochlorothiazide
  • Active Comparator: 1
    Intervention: Drug: trandolapril/verapamil
  • Active Comparator: 2
    Intervention: Drug: (Hyzaar) losartan/hydrochlorothiazide
Bakris G, Molitch M, Hewkin A, Kipnes M, Sarafidis P, Fakouhi K, Bacher P, Sowers J; STAR Investigators. Differences in glucose tolerance between fixed-dose antihypertensive drug combinations in people with metabolic syndrome. Diabetes Care. 2006 Dec;29(12):2592-7. Erratum in: Diabetes Care. 2007 May;30(5):1329.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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April 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Peter Bacher, MD, PhD, Abbott
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Study Director: Global Medical Information Abbott
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP