Lesinurad and Febuxostat Combination Extension Study in Gout

Last updated: January 3, 2018
Sponsor: Ardea Biosciences, Inc.
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Musculoskeletal Diseases

Arthritis And Arthritic Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01808144
RDEA594-307
2012-004390-54
  • Ages 18-85
  • All Genders

Study Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is able to understand the study procedures and the risks involved and iswilling to provide written informed consent before the first study related activity.

  • Subject completed the double-blind treatment period in Study RDEA594-304 and wasactively receiving and tolerating study medication (lesinurad or placebo) andfebuxostat 80 mg at the Month 12 visit.

  • Subject is male or female; female subjects of childbearing potential must agree to usean effective non-hormonal method of birth control during the study and for at least 14days after the last dose of study medication.

Exclusion

Exclusion Criteria:

  • Subject has any medical or psychological condition, which in the opinion of theInvestigator and/or the Medical Monitor, might create undue risk to the subject orinterfere with the subject's ability to comply with the protocol requirements, or tocomplete the study.

Study Design

Total Participants: 196
Study Start date:
March 01, 2013
Estimated Completion Date:
October 06, 2016

Study Description

This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.

Connect with a study center

  • Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Woodville South, South Australia 5011
    Australia

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  • Hobart, Tasmania 7000
    Australia

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  • Mississauga, Ontario L5M 2V8
    Canada

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  • Toronto, Ontario M9W4L6
    Canada

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  • Grafton, Auckland 1023
    New Zealand

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  • Tauranga, 3143
    New Zealand

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  • Kutno, Iodzkie 99-300
    Poland

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  • Krakow, Malopolskie 30-510
    Poland

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  • Bialystok, Podlaskie 15-430
    Poland

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  • Katowice, Slaskie 40-954
    Poland

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  • Konskie, Swietokrzyskie 26-200
    Poland

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  • Elblag, Warminsko-Mazurskie 82-300
    Poland

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  • Poznan, Wielkopolskie 60-773
    Poland

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  • Fribourg, 1708
    Switzerland

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  • Birmingham, Alabama 35211
    United States

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    Goodyear, Arizona 85395
    United States

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  • Tempe, Arizona 85282
    United States

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  • Glendale, California 91204
    United States

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  • Huntington Beach, California 92646
    United States

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  • Irvine, California 92618
    United States

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  • San Diego, California 92108
    United States

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  • Denver, Colorado 80220
    United States

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  • Englewood, Colorado 80113
    United States

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  • Boynton Beach, Florida 33472
    United States

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  • Naples, Florida 34102
    United States

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  • Pembroke Pines, Florida 33027
    United States

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  • Tampa, Florida 33606
    United States

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  • Winter Haven, Florida 33880
    United States

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  • Johns Creek, Georgia 30097
    United States

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    Newnan, Georgia 30265
    United States

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  • Honolulu, Hawaii 96814
    United States

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  • Meridian, Idaho 83646
    United States

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  • Gurnee, Illinois 60031
    United States

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  • Springfield, Illinois 62704
    United States

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  • Elizabethtown, Kentucky 42701
    United States

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  • Frederick, Maryland 21702
    United States

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  • Ann Arbor, Michigan 48109
    United States

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  • Southfield, Michigan 48034
    United States

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  • Jackson, Mississippi 39202
    United States

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  • Olive Branch, Mississippi 38654
    United States

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  • Jefferson City, Missouri 65109
    United States

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  • Saint Louis, Missouri 63117
    United States

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  • New York, New York 10036
    United States

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  • Wilmington, North Carolina 28401
    United States

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  • Fargo, North Dakota 58103
    United States

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  • Columbus, Ohio 43203
    United States

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  • Middleburg Heights, Ohio 44130
    United States

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  • Wadsworth, Ohio 44281
    United States

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  • Oklahoma City, Oklahoma 73103
    United States

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  • Belle Vernon, Pennsylvania 15012
    United States

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    Clairton, Pennsylvania 15025
    United States

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    Jenkintown, Pennsylvania 19046
    United States

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  • Lansdale, Pennsylvania 19446
    United States

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  • Pittsburgh, Pennsylvania 15206
    United States

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  • Sellersville, Pennsylvania 18960
    United States

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  • Columbia, South Carolina 29204
    United States

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  • Mount Pleasant, South Carolina 29464
    United States

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  • Spartanburg, South Carolina 29303
    United States

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  • Memphis, Tennessee 38119
    United States

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  • Austin, Texas 78758
    United States

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  • Dallas, Texas 75218
    United States

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  • Houston, Texas 77074
    United States

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  • San Antonio, Texas 78229
    United States

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  • Sugar Land, Texas 77479
    United States

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  • Victoria, Texas 77901
    United States

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  • Waco, Texas 76710
    United States

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  • Chesapeake, Virginia 23320
    United States

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  • Danville, Virginia 24541
    United States

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  • Richmond, Virginia 23235
    United States

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  • Seattle, Washington 98104
    United States

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  • Morgantown, West Virginia 26505
    United States

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