Status:
COMPLETED
Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Abbott RDx Cardiometabolic
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if rosiglitazone treatment improves integrated cardiovascular performance in patients at risk for congestive heart failure. A second aim of this study is to d...
Detailed Description
Cardiovascular disease (CVD), including congestive heart failure (CHF), accounts for over 75% of deaths among patients with diabetes. Thus, it is imperative to rigorously evaluate existing and emergin...
Eligibility Criteria
Inclusion
- type 2 diabetes mellitus (prior clinical diagnosis and current use of hypoglycemic medical therapy or by new diagnosis according to ADA criteria) with at least one of the following:
- prior diagnosis of cardiovascular disease (CAD, MI, revascularization, CVA/TIA, carotid or peripheral arterial disease)
- at least one additional CVD risk factor (smoking, hypertension, hypercholesterolemia, albuminuria, family history of premature CAD, or documented hsCRP\>3)
Exclusion
- treatment with a TZD within prior 6 months
- documented intolerance to TZD
- history or evidence of CHF
- AST/ALT\>3X upper limits of normal
- creatinine \>2.5
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00424762
Start Date
February 1 2005
End Date
April 1 2007
Last Update
April 4 2012
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9034