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

Primary Purpose

Hypertension, Metabolic Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
trandolapril/verapamil
(Hyzaar) losartan/hydrochlorothiazide
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Metabolic Syndrome, Tarka, Hyzaar

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Oral Glucose Tolerance

    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.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    July 11, 2008
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00234858
    Brief Title
    Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR)
    Acronym
    STAR
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    April 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Metabolic Syndrome
    Keywords
    Hypertension, Metabolic Syndrome, Tarka, Hyzaar

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    280 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Title
    2
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    trandolapril/verapamil
    Other Intervention Name(s)
    ABT-TARKA, Tarka
    Intervention Description
    2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
    Intervention Type
    Drug
    Intervention Name(s)
    (Hyzaar) losartan/hydrochlorothiazide
    Other Intervention Name(s)
    Hyzaar, losartan/hydrochlorothiazide
    Intervention Description
    50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD
    Primary Outcome Measure Information:
    Title
    Oral Glucose Tolerance
    Time Frame
    up to 1 year / 52 weeks
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Medical Information
    Organizational Affiliation
    Abbott
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17130190
    Citation
    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. doi: 10.2337/dc06-1373. Erratum In: Diabetes Care. 2007 May;30(5):1329.
    Results Reference
    derived

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

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