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OpenTrials
Completed

NCT Number: NCT00234858

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

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

trandolapril/verapamil

Drug

2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD

Other names: ABT-TARKA, Tarka

(Hyzaar) losartan/hydrochlorothiazide

Drug

50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD

Other names: Hyzaar, losartan/hydrochlorothiazide

Primary outcomes

  1. Oral Glucose Tolerance

    Time frame: up to 1 year / 52 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Acronym: STAR

Important dates

Study start
2004
Primary completion
2006
First posted
Oct 10, 2005
Registry last updated
Jul 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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