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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Metabolic Syndrome

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

Phase: Phase 4

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Global Medical Information, Study Director, Affiliation: Abbott


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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Oral Glucose Tolerance

Secondary outcome: 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.


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: March 2004
Last updated: July 11, 2008

Page last updated: August 23, 2015

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