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

Abbott0 sites280 target enrollmentMarch 2004

ConditionsHypertension Metabolic Syndrome

Interventionstrandolapril/verapamil (Hyzaar) losartan/hydrochlorothiazide

Drugstrandolapril/verapamil (Hyzaar) losartan/hydrochlorothiazide

Overview

Phase: Phase 4
Intervention: trandolapril/verapamil
Conditions: Hypertension
Sponsor: Abbott
Enrollment: 280
Primary Endpoint: Oral Glucose Tolerance
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

April 2006

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

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.

Arms & Interventions

1

Intervention: trandolapril/verapamil

2

Intervention: (Hyzaar) losartan/hydrochlorothiazide

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.(up to 1 year / 52 weeks)