Trial Information

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 Cardiovascular Comorbidities

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
Stroke
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)
hyperuricemia
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:

Subject has secondary hyperuricemia (eg. due to myeloproliferative disorder or organ transplant).
Subject has a history of xanthinuria.
The subject has received urate-lowering therapy (i.e., febuxostat, allopurinol, probenecid, etc.) or excluded medication during the screening period (beginning at Screening).
Subject has a known hypersensitivity to any component of the febuxostat or allupurinol or any components of their formulation.
The subject has active peptic ulcer disease.
The subject has history of cancer, except basal cell carcinoma of the skin, within 5 years prior to the first dose of study medication.
The subject had a myocardial infarction (MI) or stroke within the 60 days prior to the Screening visit.
Subject has ALT and/ or AST values great than 2.0 the upper limit of normal during the Screening period.
Subject has a significant medical condition and/ or conditions that would interfere with the treatment, safety or compliance with the protocol.
The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the Screening visit or the subject consumes more than 14 alcoholic beverages/ week.
The subject received any investigational medicinal product within 30 days prior to the Screening visit and throughout the study.
The subject's estimated creatinine clearance (eCLcr) is less than 30 mL/min, where creatinine clearance is calculated using the Cockcroft and Gault formula based on the Ideal Body Weight (IBW).
The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg spouse, parent, child, and sibling) or may consent under duress.
Subject is required to take excluded medications:

Any urate-lowering drug other than study medication
Salicylates (chronic use of aspirin =325 mg/day is allowed).
Azathioprine
Mercaptopurine
Theophylline
Intravenous colchicine
Pyrazinamide.
Sulfamethoxazole/trimethoprim.
Macrolides or ketolides, only when a subject is receiving concomitant colchicine.
Clopidogrel, (only if subject is receiving concomitant naproxen).

The following restrictions also apply during the study:

Long-term (>4 continuous weeks) use of high dose corticosteroids (prednisone>10 mg/day or its equivalent) is not allowed.
The chronic use of prednisone =10 mg/day (or its equivalent) and short-term use of higher doses of prednisone is allowed.
Long-term use (>4 continuous weeks) of prescription or over-the-counter NSAIDs and cyclooxygenase 2 (COX-2) inhibitors, other than protocol required prophylaxis therapy supplied by Takeda, is not allowed.
Short-term use of NSAIDs and COX-2 inhibitors is allowed (short-term use is defined as a duration of =4 weeks of continuous use).

The subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

Patient Recruitment Team
Pharmax Research Clinic, Inc.
7200 NW 7th Street, Suite 350
Miami, FL 33126
Phone: 305-262-4321
Fax: 305-262-4062
Email: info@pharmaxrc.com

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Research Center Information: Pharmax Research Clinic, Inc.

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