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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234858

Acronym

STAR

Enrollment

280

Registered

2005-10-10

Start date

2004-03-31

Completion date

Unknown

Last updated

2008-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Metabolic Syndrome

Keywords

Hypertension, Metabolic Syndrome, Tarka, Hyzaar

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

Interventions

DRUGtrandolapril/verapamil

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

DRUG(Hyzaar) losartan/hydrochlorothiazide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Oral Glucose Tolerance	up to 1 year / 52 weeks

Secondary

Measure	Time frame
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.	up to 1 year / 52 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026