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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