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

Abbott

Status and phase: Completed; Phase 4

Conditions: Hypertension; Metabolic Syndrome

Treatments: Drug: trandolapril/verapamil; Drug: (Hyzaar) losartan/hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234858

M03-598

Details and patient eligibility

About

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

Enrollment: 280 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: trandolapril/verapamil

2

Active Comparator group

Treatment:

Drug: (Hyzaar) losartan/hydrochlorothiazide