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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234858
First received: September 13, 2005
Last updated: July 11, 2008
Last verified: June 2008

September 13, 2005
July 11, 2008
March 2004
April 2006   (final data collection date for primary outcome measure)
Oral Glucose Tolerance [ Time Frame: up to 1 year / 52 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00234858 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
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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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
    • ABT-TARKA
    • trandolapril/verapamil
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
Not Provided
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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00234858
M03-598
No
Peter Bacher, MD, PhD, Abbott
Abbott
Not Provided
Study Director: Global Medical Information Abbott
Abbott
June 2008

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