Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR)
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Metabolic Syndrome
Intervention: Tarka (trandolapril/verapamil) (Drug); Hyzaar (losartan/hydrochlorothiazide) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Global Medical Information, Study Director, Affiliation: Abbott
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
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Oral Glucose Tolerance
Secondary outcome: 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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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,
Locations and Contacts
Additional Information
Starting date: March 2004
Ending date: April 2006
Last updated: August 30, 2007
|
