Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cardiovascular Safety of Febuxostat and Allopurinol in Patients With Gout and Cardiovascular Comorbidities (CARES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Takeda
Sponsor:
Collaborator:
Teijin
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01101035
First received: April 7, 2010
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events). Examples of major cardiovascular events include heart attacks, strokes, and angina (chest pain due to narrowing of the blood vessels of the heart) that need to be treated urgently with a heart operation. The overall duration of the study is dependent on the number of predefined major cardiovascular events (MACE). The length of study is expected to be approximately 9 years in order to observe the required 624 MACE. The length of study participation for each subject will vary due to the event driven study design.

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.


Condition Intervention Phase
Cardiovascular Disease
Drug: Febuxostat
Drug: Allopurinol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • First occurrence of any event in the predefined Major Adverse Cardiovascular Events Composite. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of any event in the predefined Major Adverse Cardiovascular Events (MACE) Composite, which includes: Cardiovascular death, Non-fatal Myocardial Infarction, Nonfatal Stroke and Unstable Angina with Urgent Coronary Revascularization.


Secondary Outcome Measures:
  • First occurrence of any Antiplatelet Trialists' Collaborative Event. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of any Antiplatelet Trialists' Collaborative Event, which includes Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke.

  • First occurrence of Cardiovascular Death death. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of Cardiovascular Death.

  • First occurrence of Non-fatal Myocardial Infarction. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of nonfatal Myocardial Infarction.

  • First occurrence of Non-fatal stroke. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of Non-fatal Stroke.

  • First occurrence of Unstable Angina with Urgent Coronary Revascularization. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of Unstable Angina with Urgent Coronary Revascularization.


Estimated Enrollment: 7500
Study Start Date: April 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Febuxostat 40 mg or 80 mg QD
(dependent on serum uric acid levels)
Drug: Febuxostat
Febuxostat 40 mg or 80 mg (depending on serum uric acid levels), capsules, orally, once daily for up to 60 months.
Other Names:
  • Uloric
  • TMX-67
Active Comparator: Allopurinol 200 mg to 600 mg QD
(dependent on renal function)
Drug: Allopurinol
Allopurinol 200 mg to 600 mg (depending on renal function), capsules, orally, once daily for up to 60 months.
Other Names:
  • Zyloprim
  • Allohexal
  • Allosig
  • Milurit
  • Alloril
  • Progout
  • Zyloric
  • Puricos
  • Zyrik 300
  • Aluron

Detailed Description:

This is a phase 3B multicenter, randomized, double-blind, active-controlled study designed to evaluate the cardiovascular (CV) safety of febuxostat compared with allopurinol in subjects with gout and significant CV comorbidities. Approximately 7500 subjects, males 50 years of age or older or females 55 years of age or older (at least 2-years post-menopausal), with gout and health problems affecting the heart or blood vessels will take part in this study at approximately 450 study centers in North America.

This study will use competitive enrollment. This means that when a target number of subjects has entered the treatment phase of the study, all further screening of subjects will be closed. The length of the study is based on an ongoing review of study results. The participation will last a maximum of 9 years and will include a maximum 28 visits to the study center. Telephone contact will be made every 2 months for subjects who have discontinued the study drug for any reason, but who are asked to continue in the study to be followed for potential cardiovascular events. This study design is called a "Time to Event Study". All study subjects will continue to be followed until enough information has been gathered to determine the overall safety of the study drug.

Gout is caused by high levels of uric acid in the body, and is associated with a broad range of conditions including heart disease, chronic kidney disease and additional risk factors like obesity and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form from supersaturated body fluids and settle in joints and other organs.

People with gout may also have a higher incidence of other conditions that may be associated with hyperuricemia, gout or both. This is supported by a growing body of research demonstrating that serum urate levels are an independent predictive factor for cardiovascular disease when the effects of other risk factors have been controlled.

This study will explore the cardiovascular safety of febuxostat to determine whether the use of febuxostat is associated with a moderate increase in the risk of serious adverse cardiovascular outcomes as compared to allopurinol.

Participation will last a maximum of 5 years and will include 15 to 20 visits to the study center.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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 of major CV or cerebrovascular disease including at least one of the following:

    • MI.
    • Hospitalized unstable angina.
    • Cardiac or cerebrovascular revascularization procedure.
    • Stroke.
    • Hospitalized TIA.
    • Peripheral vascular disease (ankle brachial index ≤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).
  4. 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:

    • 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.
  5. The subjects must have either:

    • a sUA level ≥7.0 mg/dL (≥416 μmol/L) at the Day -7 Visit OR
    • a sUA level ≥6.0 mg/dL (≥354 μmol/L) at the Day -7 Visit AND inadequately controlled gout (≥1 flare in the 12 months prior to screening and/or the presence of tophi).
  6. The subject is capable of understanding and complying with protocol requirements

Exclusion Criteria:

Subjects who meet any of the following criteria will not qualify for entry into this study:

  1. The subject has secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant).
  2. The subject has a history of xanthinuria.
  3. The subject has received urate-lowering therapy (i.e., febuxostat, allopurinol, probenecid, etc.) or excluded medication during the screening period (beginning with Day -7).
  4. The subject has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation.
  5. The subject has active peptic ulcer disease.
  6. The subject has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the first dose of study medication.
  7. The subject had MI or stroke within 60 days prior to the Screening Visit.
  8. The subject has ALT and/or AST values greater than 2 times the upper limit of normal (×ULN) during the Screening period.
  9. The subject has a significant medical condition and/or conditions that would interfere with the treatment, safety, or compliance with the protocol.
  10. 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 >14 alcoholic beverages per week.
  11. The subject has received any investigational medicinal product within the 30 days prior to the Screening Visit and throughout the study.
  12. The subject's estimated CLcr is <30 mL/min, where CLcr is calculated using the Cockcroft and Gault formula based on ideal body weight (IBW),
  13. 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, sibling) or may consent under duress.
  14. The subject is required to take excluded medications
  15. The subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101035

Contacts
Contact: Takeda Study Registration Call Center 888-361-3630 ctgovinfo@goutstudynow.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Athens, Alabama, United States
Recruiting
Birmingham, Alabama, United States
Active, not recruiting
Calera, Alabama, United States
Recruiting
Columbiana, Alabama, United States
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Gulf Shores, Alabama, United States
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Homewood, Alabama, United States
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Hoover, Alabama, United States
Completed
Hueytown, Alabama, United States
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Huntsville, Alabama, United States
Completed
Mobile, Alabama, United States
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Mobile, Alabama, United States
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North Alabaster, Alabama, United States
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Ozark, Alabama, United States
Completed
Tallassee, Alabama, United States
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Tuscaloosa, Alabama, United States
United States, Arizona
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Goodyear, Arizona, United States
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Green Valley, Arizona, United States
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Mesa, Arizona, United States
Completed
Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Sierra Vista, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
United States, Arkansas
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
United States, California
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Anaheim, California, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Buena Park, California, United States
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Carlsbad, California, United States
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El Cajon, California, United States
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Greenbrae, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Palmdale, California, United States
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Paramount, California, United States
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Poway, California, United States
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Rancho Cucamonga, California, United States
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Riverside, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Jose, California, United States
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United States, Connecticut
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Middlebury, Connecticut, United States
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Milford, Connecticut, United States
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Stamford, Connecticut, United States
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Trumbull, Connecticut, United States
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Trumbull, Connecticut, United States
United States, Florida
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Aventura, Florida, United States
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Boca Raton, Florida, United States
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Boynton Beach, Florida, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Cutler Bay, Florida, United States
Completed
Cutler Bay, Florida, United States
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Daytona Beach, Florida, United States
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Fleming Island, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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New Smyrna Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Sarasota, Florida, United States
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South Miami, Florida, United States
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St Cloud, Florida, United States
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St Petersburg, Florida, United States
Completed
St Petersburg, Florida, United States
Completed
St. Cloud, Florida, United States
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St. Petersburg, Florida, United States
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Summerfield, Florida, United States
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Tamarac, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Winter Haven, Florida, United States
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United States, Georgia
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Calhoun, Georgia, United States
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Conyers, Georgia, United States
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Decatur, Georgia, United States
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Arlington Heights, Illinois, United States
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Buffalo Grove, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
Completed
Evanston, Illinois, United States
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Evergreen Park, Illinois, United States
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Evergreen Park, Illinois, United States
Completed
Maywood, Illinois, United States
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Maywood, Illinois, United States
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Melrose Park, Illinois, United States
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Morton, Illinois, United States
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Naperville, Illinois, United States
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Bloomington, Indiana, United States
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Lafayette, Indiana, United States
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Lafayette, Indiana, United States
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Valparaiso, Indiana, United States
United States, Iowa
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Iowa City, Iowa, United States
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Lenexa, Kansas, United States
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Overland Park, Kansas, United States
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Shawnee, Kansas, United States
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United States, Kentucky
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Elizabethtown, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Paducah, Kentucky, United States
United States, Louisiana
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Mer Rouge, Louisiana, United States
Completed
Mer Rouge, Louisiana, United States
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Monroe, Louisiana, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Shreveport, Louisiana, United States
United States, Maine
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Biddeford, Maine, United States
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Rockport, Maine, United States
United States, Maryland
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Baltimore, Maryland, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Lutherville, Maryland, United States
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Oxon Hill, Maryland, United States
Completed
Rockville, Maryland, United States
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Wheaton, Maryland, United States
United States, Massachusetts
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Brockton, Massachusetts, United States
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Fall River, Massachusetts, United States
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Hyannis, Massachusetts, United States
Completed
Hyannis, Massachusetts, United States
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Worcester, Massachusetts, United States
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Worchester, Massachusetts, United States
United States, Michigan
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Ann Arbor, Michigan, United States
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Bingham Farms, Michigan, United States
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Chelsea, Michigan, United States
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Detroit, Michigan, United States
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Flint, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
United States, Minnesota
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Brooklyn Center, Minnesota, United States
Completed
Brooklyn Center, Minnesota, United States
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Chaska, Minnesota, United States
Completed
Chaska, Minnesota, United States
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Duluth, Minnesota, United States
Completed
Duluth, Minnesota, United States
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Edina, Minnesota, United States
United States, Mississippi
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Jackson, Mississippi, United States
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Olive Branch, Mississippi, United States
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Port Gibson, Mississippi, United States
United States, Missouri
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Clarkson Valley, Missouri, United States
Completed
Clarkson Valley, Missouri, United States
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Florissant, Missouri, United States
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Hazelwood, Missouri, United States
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Kansas, Missouri, United States
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Kansas City, Missouri, United States
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St Charles, Missouri, United States
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St Louis, Missouri, United States
Completed
St. Charles, Missouri, United States
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St. Louis, Missouri, United States
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Washington, Missouri, United States
United States, Montana
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Billings, Montana, United States
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Butte, Montana, United States
United States, Nebraska
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Bellevue, Nebraska, United States
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Grand Island, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
United States, Nevada
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
United States, New Jersey
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Brick, New Jersey, United States
Completed
Cherry Hill, New Jersey, United States
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Edison, New Jersey, United States
Completed
Lawrenceville, New Jersey, United States
Completed
Lumberton, New Jersey, United States
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Lumberton, New Jersey, United States
Completed
Medford, New Jersey, United States
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Medford, New Jersey, United States
Completed
Oradell, New Jersey, United States
United States, New Mexico
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Albuquerque, New Mexico, United States
United States, New York
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Brooklyn, New York, United States
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Endwell, New York, United States
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Freeport, New York, United States
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Glens Falls, New York, United States
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Mineola, New York, United States
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New Windsor, New York, United States
Completed
Poughkeepsie, New York, United States
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Poughkeepsie, New York, United States
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Rochester, New York, United States
Completed
Smithtown, New York, United States
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West Seneca, New York, United States
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Westfield, New York, United States
United States, North Carolina
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Asheboro, North Carolina, United States
Completed
Burlington, North Carolina, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Greensboro, North Carolina, United States
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Harrisburg, North Carolina, United States
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Huntersville, North Carolina, United States
Completed
Huntersville, North Carolina, United States
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Lenior, North Carolina, United States
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Lenoir, North Carolina, United States
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Monroe, North Carolina, United States
Recruiting
Raleigh, North Carolina, United States
Recruiting
Salisbury, North Carolina, United States
Recruiting
Shelby, North Carolina, United States
Recruiting
Wilmington, North Carolina, United States
Recruiting
Winston-Salem, North Carolina, United States
United States, North Dakota
Recruiting
Fargo, North Dakota, United States
United States, Ohio
Recruiting
Akron, Ohio, United States
Recruiting
Centerville, Ohio, United States
Recruiting
Cincinnati, Ohio, United States
Recruiting
Columbus, Ohio, United States
Recruiting
Dayton, Ohio, United States
Recruiting
Delaware, Ohio, United States
Recruiting
Franklin, Ohio, United States
Recruiting
Kettering, Ohio, United States
Recruiting
Lyndhurst, Ohio, United States
Recruiting
Marion, Ohio, United States
Recruiting
Mentor, Ohio, United States
Recruiting
Middleburg Heights, Ohio, United States
Recruiting
Perrysburg, Ohio, United States
Recruiting
Toledo, Ohio, United States
Recruiting
Willoughby, Ohio, United States
Recruiting
Willoughby Hills, Ohio, United States
Completed
Willoughby Hills, Ohio, United States
United States, Oklahoma
Completed
Norman, Oklahoma, United States
Recruiting
Oklahoma City, Oklahoma, United States
Recruiting
Tulsa, Oklahoma, United States
United States, Oregon
Recruiting
Ashland, Oregon, United States
Recruiting
Bend, Oregon, United States
Recruiting
Eugene, Oregon, United States
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Altoona, Pennsylvania, United States
Recruiting
Bensalem, Pennsylvania, United States
Recruiting
Bethlehem, Pennsylvania, United States
Recruiting
Downingtown, Pennsylvania, United States
Recruiting
Duncansville, Pennsylvania, United States
Recruiting
Ephrata, Pennsylvania, United States
Recruiting
Feasterville, Pennsylvania, United States
Completed
Harrisburg, Pennsylvania, United States
Completed
Holland, Pennsylvania, United States
Recruiting
Lansdale, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
Recruiting
Pittsburgh, Pennsylvania, United States
Recruiting
Quakertown, Pennsylvania, United States
Recruiting
Upper St Clair, Pennsylvania, United States
Recruiting
Wyomissing, Pennsylvania, United States
United States, Rhode Island
Completed
Cranston, Rhode Island, United States
Recruiting
Cranston, Rhode Island, United States
Completed
Cumberland, Rhode Island, United States
Recruiting
Cumberland, Rhode Island, United States
Recruiting
East Providence, Rhode Island, United States
Completed
East Providence, Rhode Island, United States
United States, South Carolina
Completed
Anderson, South Carolina, United States
Recruiting
Anderson, South Carolina, United States
Recruiting
Charleston, South Carolina, United States
Recruiting
Columbia, South Carolina, United States
Recruiting
Greenville, South Carolina, United States
Recruiting
Greenwood, South Carolina, United States
Recruiting
Greer, South Carolina, United States
Recruiting
Hodges, South Carolina, United States
Completed
Murrells Inlet, South Carolina, United States
Recruiting
Murrells Inlet, South Carolina, United States
Recruiting
Myrtle Beach, South Carolina, United States
Recruiting
Orangeburg, South Carolina, United States
Recruiting
Pelzer, South Carolina, United States
Recruiting
Rock Hill, South Carolina, United States
Recruiting
Simpsonville, South Carolina, United States
Recruiting
Spartanburg, South Carolina, United States
United States, Tennessee
Recruiting
Athens, Tennessee, United States
Recruiting
Chattanooga, Tennessee, United States
Recruiting
Clarksville, Tennessee, United States
Completed
Cleveland, Tennessee, United States
Recruiting
Collierville, Tennessee, United States
Recruiting
Fayetteville, Tennessee, United States
Recruiting
Fayetville, Tennessee, United States
Completed
Germantown, Tennessee, United States
Recruiting
Jackson, Tennessee, United States
Recruiting
Kingsport, Tennessee, United States
Recruiting
Memphis, Tennessee, United States
Recruiting
New Tazewell, Tennessee, United States
United States, Texas
Recruiting
Allen, Texas, United States
Completed
Allen, Texas, United States
Recruiting
Bellaire, Texas, United States
Recruiting
Carrollton, Texas, United States
Completed
Corpus Christi, Texas, United States
Recruiting
Dallas, Texas, United States
Completed
DeSoto, Texas, United States
Recruiting
DeSoto, Texas, United States
Recruiting
El Paso, Texas, United States
Recruiting
Fort Worth, Texas, United States
Recruiting
Grapevine, Texas, United States
Recruiting
Houston, Texas, United States
Recruiting
Irving, Texas, United States
Completed
Mesquite, Texas, United States
Recruiting
Nassau Bay, Texas, United States
Recruiting
New Braunfels, Texas, United States
Recruiting
Odessa, Texas, United States
Recruiting
Plano, Texas, United States
Recruiting
Richardson, Texas, United States
Recruiting
San Antonio, Texas, United States
Completed
Southlake, Texas, United States
Recruiting
Southlake, Texas, United States
Recruiting
Sugar Land, Texas, United States
Recruiting
Tomball, Texas, United States
Recruiting
Waco, Texas, United States
Completed
Waco, Texas, United States
United States, Utah
Recruiting
Bountiful, Utah, United States
Recruiting
Draper, Utah, United States
Recruiting
Salt Lake City, Utah, United States
Completed
St George, Utah, United States
Recruiting
West Jordan, Utah, United States
United States, Virginia
Recruiting
Alexandria, Virginia, United States
Recruiting
Arlington, Virginia, United States
Active, not recruiting
Burke, Virginia, United States
Recruiting
Burke, Virginia, United States
Recruiting
Danville, Virginia, United States
Recruiting
Manassas, Virginia, United States
Recruiting
Norfolk, Virginia, United States
Recruiting
Richmond, Virginia, United States
Recruiting
Salem, Virginia, United States
Recruiting
Virginia Beach, Virginia, United States
United States, Washington
Recruiting
Port Orchard, Washington, United States
Completed
Tacoma, Washington, United States
Recruiting
Tacoma, Washington, United States
United States, West Virginia
Recruiting
Clarksburg, West Virginia, United States
United States, Wisconsin
Recruiting
Green Bay, Wisconsin, United States
Completed
Menomonee Falls, Wisconsin, United States
Recruiting
Milwaukee, Wisconsin, United States
Completed
New Berlin, Wisconsin, United States
Recruiting
Oregon, Wisconsin, United States
Recruiting
Wauwatosa, Wisconsin, United States
Recruiting
Weston, Wisconsin, United States
Completed
Weston, Wisconsin, United States
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Completed
Langley, British Columbia, Canada
Completed
Victoria, British Columbia, Canada
Canada, Newfoundland and Labrador
Recruiting
Saint John's, Newfoundland and Labrador, Canada
Canada, Ontario
Recruiting
Brampton, Ontario, Canada
Active, not recruiting
Corunna, Ontario, Canada
Recruiting
Hamilton, Ontario, Canada
Recruiting
London, Ontario, Canada
Recruiting
Thornhill, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Completed
Montreal, Quebec, Canada
Recruiting
St-Georges, Beauce, Quebec, Canada
Recruiting
St-Jérome, Quebec, Canada
Canada
Recruiting
Brampton, ON, Canada
Recruiting
Edmonton, AB, Canada
Recruiting
Hamilton, ON, Canada
Recruiting
Langley, BC, Canada
Recruiting
London, ON, Canada
Recruiting
Quebec, Canada
Recruiting
Quebec, QC, Canada
Recruiting
Sarnia, ON, Canada
Recruiting
St Johns, NF, Canada
Recruiting
Thornhill, ON, Canada
Recruiting
Toronto, ON, Canada
Mexico
Recruiting
Mexicali, Baja California, Mexico
Recruiting
Tijuana, Baja California, Mexico
Recruiting
Mexico, D.f., Mexico
Recruiting
Mexico, DF, Mexico
Recruiting
Mexico, Distrito Federal, Mexico
Recruiting
Mexico, Edo. de Mexico, Mexico
Not yet recruiting
Celaya, Guanajuato, Mexico
Not yet recruiting
Pachuca, HIdalgo, Mexico
Recruiting
Guadalajara, Jalisco, Mexico
Recruiting
Puerto Vallarta, Jalisco, Mexico
Completed
Zapopan, Jalisco, Mexico
Completed
Cuernavaca, Morelos, Mexico
Recruiting
Monterrey, Nuevo Leon, Mexico
Recruiting
Tampico, Tamaulipas, Mexico
Recruiting
Xalapa, Veracruz, Mexico
Recruiting
Merida, Yucatan, Mexico
Completed
Aguascalientes, Mexico
Recruiting
Chihuahua, Mexico
Recruiting
Durango, Mexico
Recruiting
Mexico, Mexico
Recruiting
Queretaro, Mexico
Recruiting
San Luis Potosi, Mexico
Recruiting
Veracruz, Mexico
Sponsors and Collaborators
Takeda
Teijin
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01101035     History of Changes
Other Study ID Numbers: TMX-67_301, U1111-1114-4194
Study First Received: April 7, 2010
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
cardiovascular outcomes
heart attack
stroke
Drug Therapy
physiology
Hyperuricemia
Uric Acid

Additional relevant MeSH terms:
Cardiovascular Diseases
Allopurinol
Febuxostat
Antimetabolites
Antioxidants
Antirheumatic Agents
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014