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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines High Blood Pressure Metabolic Syndrome

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

U.S. FDA Resources

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
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

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

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

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Abbott:

Hypertension
Metabolic Syndrome
Tarka
Hyzaar

Additional relevant MeSH terms:

Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Verapamil
Diltiazem
Losartan
Hydrochlorothiazide
Trandolapril
Vasodilator Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on February 09, 2012