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

June 12, 2018 updated by: Takeda

A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The drug tested in this study was called Febuxostat (TMX-67). Febuxostat compared with allopurinol was evaluated for the cardiovascular (CV) safety in people with gout and significant CV comorbidities.

The study enrolled 6198 patients. Participants with a diagnosis of gout were enrolled in a 1:1 ratio to receive either:

  • Febuxostat
  • Allopurinol

Participants received febuxostat 40 mg or 80 mg for the study depending on their serum uric acid levels were either <6.0 mg/dL or ≥6.0 mg/dL during specified visits. Allopurinol 200 mg to 400 mg (for moderate renal impairment),or 300 mg to 600 mg (for normal and mild renal impairment), increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL was received.

This multi-center trial was conducted in Canada, Mexico and United States. The overall time to participate in this study was approximately 7 years (84 months). Participants made multiple visits to the clinic and were also contacted through the telephone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Jalisco, Distrito Federal, Mexico
  • United States
    • Georgia
      • Decatur, Georgia, United States
      • Dunwoody, Georgia, United States
      • Marietta, Georgia, United States
      • Norcross, Georgia, United States
      • Roswell, Georgia, United States
      • Suwanee, Georgia, United States
      • Waycross, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Idaho
      • Boise, Idaho, United States
      • Coeur d'Alene, Idaho, United States
      • Nampa, Idaho, United States
    • Illinois
      • Addison, Illinois, United States
      • Arlington Heights, Illinois, United States
      • Evanston, Illinois, United States
      • Evergreen Park, Illinois, United States
      • Flossmoor, Illinois, United States
      • Melrose Park, Illinois, United States
      • Morton, Illinois, United States
      • Naperville, Illinois, United States
      • Quincy, Illinois, United States
      • Rockford, Illinois, United States
    • Indiana
      • Bloomington, Indiana, United States
      • Brownsburg, Indiana, United States
      • Lafayette, Indiana, United States
      • Valparaiso, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Lenexa, Kansas, United States
      • Overland Park, Kansas, United States
      • Topeka, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Elizabethtown, Kentucky, United States
      • Lexington, Kentucky, United States
      • Owensboro, Kentucky, United States
      • Paducah, Kentucky, United States
    • Louisiana
      • Mer Rouge, Louisiana, United States
      • Monroe, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maine
      • Biddeford, Maine, United States
      • Rockport, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Cumberland, Maryland, United States
      • Hagerstown, Maryland, United States
      • Lutherville, Maryland, United States
      • Wheaton, Maryland, United States
    • Massachusetts
      • Brockton, Massachusetts, United States
      • Fall River, Massachusetts, United States
      • Hyannis, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Bingham Farms, Michigan, United States
      • Chelsea, Michigan, United States
      • Detroit, Michigan, United States
      • Flint, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lansing, Michigan, United States
    • Minnesota
      • Chaska, Minnesota, United States
      • Duluth, Minnesota, United States
      • Edina, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
      • Olive Branch, Mississippi, United States
      • Port Gibson, Mississippi, United States
    • Missouri
      • Clarkson Valley, Missouri, United States
      • Hazelwood, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Charles, Missouri, United States
      • Saint Louis, Missouri, United States
      • Washington, Missouri, United States
    • Montana
      • Billings, Montana, United States
      • Butte, Montana, United States
    • Nebraska
      • Bellevue, Nebraska, United States
      • Grand Island, Nebraska, United States
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • Nevada
      • Henderson, Nevada, United States
      • Las Vegas, Nevada, United States
      • Reno, Nevada, United States
    • New Jersey
      • Brick, New Jersey, United States
      • Edison, New Jersey, United States
      • Oradell, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
      • Las Vegas, New Mexico, United States
    • New York
      • Endwell, New York, United States
      • Freeport, New York, United States
      • Glens Falls, New York, United States
      • Mineola, New York, United States
      • New Windsor, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • West Seneca, New York, United States
      • Westfield, New York, United States
    • North Carolina
      • Asheboro, North Carolina, United States
      • Cary, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Columbia, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Huntersville, North Carolina, United States
      • Lenoir, North Carolina, United States
      • Monroe, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Shelby, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Akron, Ohio, United States
      • Centerville, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
      • Delaware, Ohio, United States
      • Franklin, Ohio, United States
      • Kettering, Ohio, United States
      • Lyndhurst, Ohio, United States
      • Marion, Ohio, United States
      • Mentor, Ohio, United States
      • Middleburg Heights, Ohio, United States
      • Toledo, Ohio, United States
      • Willoughby Hills, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Ashland, Oregon, United States
      • Bend, Oregon, United States
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
      • Bensalem, Pennsylvania, United States
      • Bethlehem, Pennsylvania, United States
      • Downingtown, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Ephrata, Pennsylvania, United States
      • Harleysville, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • McMurray, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Quakertown, Pennsylvania, United States
      • Wyomissing, Pennsylvania, United States
    • Rhode Island
      • Cumberland, Rhode Island, United States
      • East Providence, Rhode Island, United States
      • Providence, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Greenville, South Carolina, United States
      • Greenwood, South Carolina, United States
      • Greer, South Carolina, United States
      • Myrtle Beach, South Carolina, United States
      • Orangeburg, South Carolina, United States
      • Pelzer, South Carolina, United States
      • Simpsonville, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Athens, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Clarksville, Tennessee, United States
      • Collierville, Tennessee, United States
      • Fayetteville, Tennessee, United States
      • Jackson, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Memphis, Tennessee, United States
      • New Tazewell, Tennessee, United States
    • Texas
      • Bellaire, Texas, United States
      • Carrollton, Texas, United States
      • Dallas, Texas, United States
      • El Paso, Texas, United States
      • Fort Worth, Texas, United States
      • Grapevine, Texas, United States
      • Houston, Texas, United States
      • Irving, Texas, United States
      • McKinney, Texas, United States
      • New Braunfels, Texas, United States
      • Odessa, Texas, United States
      • Pearland, Texas, United States
      • Plano, Texas, United States
      • Richardson, Texas, United States
      • San Antonio, Texas, United States
      • Southlake, Texas, United States
      • Sugar Land, Texas, United States
      • Tomball, Texas, United States
      • Waco, Texas, United States
    • Utah
      • Bountiful, Utah, United States
      • Draper, Utah, United States
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Alexandria, Virginia, United States
      • Arlington, Virginia, United States
      • Burke, Virginia, United States
      • Danville, Virginia, United States
      • McLean, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Salem, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Port Orchard, Washington, United States
      • Tacoma, Washington, United States
    • West Virginia
      • Clarksburg, West Virginia, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States
      • Milwaukee, Wisconsin, United States
      • New Berlin, Wisconsin, United States
      • Oregon, Wisconsin, United States
      • Verona, Wisconsin, United States
      • Waukesha, Wisconsin, United States
      • Weston, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The participant or the participant'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 participant is male ≥50 years of age or female ≥55 years of age and at least 2-years post-menopausal.

  3. The participant 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 transient ischemic attack (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 participant 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 participants must have either:

    • a serum urate or serum uric acid (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 participant is capable of understanding and complying with protocol requirements

Exclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Febuxostat
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
Drug: Febuxostat
Febuxostat tablets
Other Names:
  • Uloric
  • TMX-67
ACTIVE_COMPARATOR: Allopurinol
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance [eCLcr] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but <60 mL/min).
Drug: Allopurinol
Allopurinol tablets
Other Names:
  • Zyloprim
  • Zyloric
  • Alloril
  • Allohexal
  • Allosig
  • Milurit
  • Progout
  • Puricos
  • Zyrik 300
  • Aluron

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis)
Time Frame: Up to last dose of study drug (approximately 83 months)
Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.
Up to last dose of study drug (approximately 83 months)
Percentage of Participants With Primary MACE Composite (Final Analysis)
Time Frame: Up to last dose of study drug (approximately 83 months)
Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.
Up to last dose of study drug (approximately 83 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Antiplatelet Trialists' Collaborative (APTC) Event
Time Frame: Up to last dose of study drug (approximately 83 months)
APTC events were defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.
Up to last dose of study drug (approximately 83 months)
Percentage of Participants With Cardiovascular (CV) Death
Time Frame: Up to last dose of study drug (approximately 83 months)
Events were adjudicated by an independent cardiovascular endpoints committee as CV death.
Up to last dose of study drug (approximately 83 months)
Percentage of Participants With Non-fatal Myocardial Infarction (MI)
Time Frame: Up to last dose of study drug (approximately 83 months)
Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal MI.
Up to last dose of study drug (approximately 83 months)
Percentage of Participants With Non-fatal Stroke
Time Frame: Up to last dose of study drug (approximately 83 months)
Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal stroke.
Up to last dose of study drug (approximately 83 months)
Percentage of Participants With Unstable Angina With Urgent Coronary Revascularization
Time Frame: Up to last dose of study drug (approximately 83 months)
Events were adjudicated by an independent cardiovascular endpoints committee as unstable angina with urgent coronary revascularization.
Up to last dose of study drug (approximately 83 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMX-67_301
  • U1111-1114-4194 (REGISTRY: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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