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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234858
First received: September 13, 2005
Last updated: July 11, 2008
Last verified: June 2008
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
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
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 24, 2014