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

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

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hypertension Metabolic Syndrome Drug: trandolapril/verapamil Drug: (Hyzaar) losartan/hydrochlorothiazide Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2004
Primary Completion Date : April 2006

Arm Intervention/treatment
Active Comparator: 1 Drug: trandolapril/verapamil
2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
Other Names:
  • Tarka
Active Comparator: 2 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

Primary Outcome Measures :
  1. Oral Glucose Tolerance [ Time Frame: up to 1 year / 52 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234858

Sponsors and Collaborators
Study Director: Global Medical Information Abbott

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Bacher, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00234858     History of Changes
Other Study ID Numbers: M03-598
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: July 15, 2008
Last Verified: June 2008

Keywords provided by Abbott:
Metabolic Syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Calcium Channel Blockers
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors