Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR) - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00234858

Purpose

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

Condition	Intervention	Phase
Hypertension Metabolic Syndrome	Drug: trandolapril/verapamil Drug: (Hyzaar) losartan/hydrochlorothiazide	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Dextrose Diltiazem Verapamil Dexverapamil Diltiazem hydrochloride Diltiazem malate Verapamil hydrochloride Trandolapril Losartan Losartan potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Abbott:

Primary Outcome Measures:

Oral Glucose Tolerance [ Time Frame: up to 1 year / 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	280
Study Start Date:	March 2004
Estimated Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: trandolapril/verapamil 2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
2: Active Comparator	Drug: (Hyzaar) losartan/hydrochlorothiazide 50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234858

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Global Medical Information

Abbott

More Information

Publications indexed to this study:

Bakris G, Molitch M, Hewkin A, Kipnes M, Sarafidis P, Fakouhi K, Bacher P, Sowers J; STAR Investigators. Differences in glucose tolerance between fixed-dose antihypertensive drug combinations in people with metabolic syndrome. Diabetes Care. 2006 Dec;29(12):2592-7. Erratum in: Diabetes Care. 2007 May;30(5):1329.

Responsible Party:	Abbott ( Peter Bacher, MD, PhD )
Study ID Numbers:	M03-598
Study First Received:	September 13, 2005
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00234858
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Hypertension
Metabolic Syndrome
Tarka
Hyzaar

Study placed in the following topic categories:

Calcium, Dietary
Losartan
Trandolapril
Verapamil
Diltiazem

Vascular Diseases
Angiotensin II
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Disease
Molecular Mechanisms of Pharmacological Action
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs
Diuretics
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Pathologic Processes
Natriuretic Agents
Syndrome
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009