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

Abbott280 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

280

Conditions

Hypertension Metabolic Syndrome

Interventions

trandolapril/verapamilDRUG

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

(Hyzaar) losartan/hydrochlorothiazideDRUG

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Oral Glucose Tolerance

Time frame: up to 1 year / 52 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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