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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 11, 2008

Start Date ^ICMJE

March 2004

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Oral Glucose Tolerance

Change History

Complete list of historical versions of study NCT00234858 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hypertension
Metabolic Syndrome

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

280

Completion Date

April 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00234858

Responsible Party

Peter Bacher, MD, PhD, Abbott

Study ID Numbers ^ICMJE

M03-598

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Medical Information

Abbott

Information Provided By

Abbott

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP