Summary:
A multicenter, randomized, active-control, phase 3b study to evaluate the cardiovascular safety of febuxostat and allopurinol in subjects with gout and cardiovascular comorbidities.
The subject or the subject’s legally acceptable representative signs and dates a written, informed consent form/Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to the initiation of any study procedures.
2. The subject is male ≥50 years of age or female ≥55 years of age and at least 2-years post-menopausal.
3. The subject has a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout [13]