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

NCT ID: NCT00234858

Last Updated: 2008-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension Metabolic Syndrome

Keywords

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Hypertension Metabolic Syndrome Tarka Hyzaar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

trandolapril/verapamil

Intervention Type DRUG

2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD

2

Group Type ACTIVE_COMPARATOR

(Hyzaar) losartan/hydrochlorothiazide

Intervention Type DRUG

50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD

Interventions

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trandolapril/verapamil

2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD

Intervention Type DRUG

(Hyzaar) losartan/hydrochlorothiazide

50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD

Intervention Type DRUG

Other Intervention Names

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ABT-TARKA Tarka Hyzaar losartan/hydrochlorothiazide

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Global Medical Information

Role: STUDY_DIRECTOR

Abbott

References

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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.

Reference Type DERIVED
PMID: 17130190 (View on PubMed)

Other Identifiers

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M03-598

Identifier Type: -

Identifier Source: org_study_id