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

Hypertension Clinical Trial

— STAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234858
• Other study ID #: M03-598
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 11, 2008
• Start date: March 2004

Study information

• Verified date: June 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Glucose Tolerance		up to 1 year / 52 weeks	Yes
Secondary	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	Yes