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Therapeutic Areas: Musculoskeletal | Rheumatology | Nephrology | Family Medicine
Disease Category: Gout (Hyperuricemia)
Location: United States, FL
Gout or Hyperuricemia, and heart problems or Diabetes?
A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the
Cardiovascular Safety of Febuxostat and Allopurinol in Subjects with Gout and
Subject eligibility will be determined on the basis of the criteria listed below:
- The subject, or the subject's legally acceptable representative signs a written informed consent form/ HIPAA Authorization prior to the initiation of any study procedures.
- The subject is male 50 years of age or older or female 55 years of age or older and at least 2 years post-menopausal.
- The subject has a history of major CV or cerebrovascular disease including at least one of the following:
- Myocardial infarction (MI)
- hospitalized unstable angina
- Cardiac or cerebrovascular revascularization procedure
- Hospitalized TIA
- Peripheral vascular disease (ankle brachial index less than or equal to 0.6, revascularization and/ or well-documented history of claudication).
- History of diabetes mellitus with evidence of micro- or macrovascular disease (retinopathy, neuropathy, nephropathy, small vessel vascular diseases).
- The subject has a history or presence of gout defined as having one more more of the following conditions of the American Rheumatism Association (ARA) criteria for the diagnosis of gout:
- A tophus proven to contain urate crystals by chemical or polarized light microscopic means and/ or
- Characteristic urate crystals in the joint fluid and/ or
- History of at least 6 of the following clinical, laboratory and x-ray phenomena:
- more than 1 attack of acute arthritis
- maximum inflammation developed within 1 day
- monoarticular arthritis
- redness observed over joints
- first metatarsophalangeal joint painful or swollen
- unilateral first metatarsophalangeal joint attack
- unilateral tarsal joint attack
- tophus (proven or suspected)
- asymmetric swelling within a joint on x-ray
- sub-cortical cysts without erosions on x-ray
- joint fluid culture negative for organisms during attacks
- The subjects must have either:
- a sUA level greater than or equal to 7.0 mg/dL at Screening Visit OR
- a sUA level greater than or equal to 6.0 mg/dL at Screening Visit AND
- inadequately controlled gout (1 or more flares in the 12 months prior to screening and/ or the presence of tophi).
- Subject is capable of understanding and complying with protocol requirements.
Subjects who meet any of the following criteria will not qualify for entry into this study:
Patient Recruitment Team
Pharmax Research Clinic, Inc.
7200 NW 7th Street, Suite 350
Miami, FL 33126
Research Center Information: Pharmax Research Clinic, Inc.
If you would like to learn more about participating in this study, please send an email message using the form below.
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