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

Phase 4

Completed

• Conditions: Hypertension; Metabolic Syndrome
• Interventions: Drug: trandolapril/verapamil; Drug: (Hyzaar) losartan/hydrochlorothiazide

• Registration Number: NCT00234858
• Lead Sponsor: Abbott

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

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Primary Completion: 2006-04
• Status Verified: 2008-06
• Last Update Submitted: 2008-07-11
• Last Update Posted: 2008-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	trandolapril/verapamil	-
2	(Hyzaar) losartan/hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
Oral Glucose Tolerance	up to 1 year / 52 weeks

Secondary Outcome Measures

Name	Time	Method
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.	up to 1 year / 52 weeks