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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00234858
First Posted: October 10, 2005
Last Update Posted: July 15, 2008
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.
Information provided by:
Abbott
  Purpose
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 Intervention Phase
Hypertension Metabolic Syndrome Drug: trandolapril/verapamil Drug: (Hyzaar) losartan/hydrochlorothiazide Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

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

Secondary Outcome 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 ]

Enrollment: 280
Study Start Date: March 2004
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: trandolapril/verapamil
2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
Other Names:
  • ABT-TARKA
  • 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

  Eligibility

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
Criteria

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.
  Contacts and Locations
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
Abbott
Investigators
Study Director: Global Medical Information Abbott
  More Information

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 Submitted: September 13, 2005
First Posted: October 10, 2005
Last Update Posted: July 15, 2008
Last Verified: June 2008

Keywords provided by Abbott:
Hypertension
Metabolic Syndrome
Tarka
Hyzaar

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