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”

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

Study Type: Interventional

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

Study Primary Completion Date: April 2006

Intervention(s) in this Clinical Trial

• Drug: trandolapril/verapamil
  • 2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
• Drug: (Hyzaar) losartan/hydrochlorothiazide
  • 50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Oral Glucose Tolerance
  • Time Frame: up to 1 year / 52 weeks
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information Study Director Abbott  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234858

Study ID Number: M03-598

ClinicalTrials.gov Identifier: NCT00234858

Health Authority: United States: Food and Drug Administration