Stamford Therapeutics Consortium

Gout / Acute Coronary Syndrome

Stamford Therapeutics Consortium is currently conducting a study on
Gout sponsored by Takeda Global Research & Development Center, Inc.


Summary: The purpose of this study is to see if subjects with gout who receive febuxostat or allopurinol, once daily (QD), have a higher rate of serious heart and blood vessel complications.

For More Information Please Contact
:
Judy Dalgin (Site Manager)
email: jdalgin@stctrials.com
telephone: 203-325-8529


Eligibility:

  • Ages Eligible for Study: 50 Years and older

  • Genders Eligible for Study: Both

  • Accepts Healthy Volunteers: No


Inclusion Criteria:

  • Has a history of major cardiovascular or cerebrovascular disease including at least one of the following:
    • Myocardial infarction
    • Hospitalized unstable angina
    • Cardiac or cerebrovascular revascularization procedure
    • Stroke
    • Hospitalized for transient ischemic attack
    • Peripheral vascular disease
    • History of diabetes mellitus with evidence of micro- or macrovascular disease

  • Has a history or presence of gout defined as having one or more of the American Rheumatism Association 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)
      • Hyperuricemia
      • Asymmetric swelling within a joint on x-ray
      • Subcortical cysts without erosions on x-ray
      • Joint fluid culture negative for organisms during attack

  • Must have either:
    • a serum urate level greater than or equal to 7.0 mg/dL at the Day -7 Visit OR
    • a serum urate level greater than or equal to 6.0 mg/dL at the Day -7 Visit AND inadequately controlled gout


Exclusion Criteria:

  • Has secondary hyperuricemia

  • Has a history of xanthinuria

  • Has received urate-lowering or excluded medication during the screening period

  • Has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation

  • Has active peptic ulcer disease

  • Has a history of cancer within 5 years prior to the first dose of study medication

  • Had a myocardial infarction or stroke within 60 days prior to the Screening Visit

  • Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2 times the upper limit of normal during the Screening period

  • Has a history of drug abuse or a history of alcohol abuse within 5 years prior to the Screening Visit or the subject consumes more than14 alcoholic beverages per week

  • Has received any investigational medicinal product within the 30 days prior to the Screening Visit and throughout the study

  • Has an estimated creatinine clearance less than 30 mL/min

  • Is required to take excluded medications

  • Has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus
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