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Sponsored by: |
Abbott |
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00234858 |
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 IV |
MedlinePlus related topics: | High Blood Pressure |
ChemIDplus related topics: | Hydrochlorothiazide Dextrose Diltiazem Verapamil Dexverapamil Diltiazem hydrochloride Diltiazem malate Verapamil hydrochloride Trandolapril Losartan Losartan potassium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 280 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator |
Drug: trandolapril/verapamil
2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
|
2: Active Comparator |
Drug: (Hyzaar) losartan/hydrochlorothiazide
50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Peter Bacher, MD, PhD ) |
Study ID Numbers: | M03-598 |
First Received: | September 13, 2005 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00234858 |
Health Authority: | United States: Food and Drug Administration |
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