Open-Label Lesinurad Monotherapy Extension Study in Gout

Last updated: April 20, 2016
Sponsor: Ardea Biosciences, Inc.
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Musculoskeletal Diseases

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01650246
RDEA594-305
  • Ages 18-85
  • All Genders

Study Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad 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 RDEA594-303 and wasactively receiving and tolerating study medication (lesinurad or placebo) at Month 6visit.

  • Subject is willing to adhere to the visit/protocol schedules.

  • 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 other 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.

  • Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stonediathesis.

  • Subject developed kidney stones during Study RDEA594-303

Study Design

Total Participants: 143
Study Start date:
August 01, 2012
Estimated Completion Date:
August 31, 2014

Study Description

This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.

Connect with a study center

  • Herston, Queensland 4029
    Australia

    Site Not Available

  • Hobart, Tasmania 7000
    Australia

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  • Genk, 3600
    Belgium

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  • Gozée, 6534
    Belgium

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  • Kortrijk, 8500
    Belgium

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  • Yvoir, 5530
    Belgium

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  • Toronto, Ontario M9W 4L6
    Canada

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  • Rimouski, Quebec G5L 8W1
    Canada

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  • Quebec, G1V 3M7
    Canada

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  • Dresden, 01069
    Germany

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  • Leipzig, 04109
    Germany

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  • Grafton, Auckland 1023
    New Zealand

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  • Tauranga, 3143
    New Zealand

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  • Silverglen, Durban 4092
    South Africa

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  • Muckleneuk, Pretoria 0002
    South Africa

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  • Rondebosch, 7700
    South Africa

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  • Stellenbosch, 7600
    South Africa

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  • Thabazimbi, 0380
    South Africa

    Site Not Available

  • Birmingham, Alabama 35294
    United States

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  • Glendale, Arizona 85308
    United States

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  • Peoria, Arizona 85381
    United States

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  • Tempe, Arizona 85282
    United States

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  • Carmichael, California 95608
    United States

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  • Covina, California 91723
    United States

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  • Huntington Park, California 90255
    United States

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  • Irvine, California 92618
    United States

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  • Colorado Springs, Colorado 80922
    United States

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  • Denver, Colorado 80230
    United States

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  • Englewood, Colorado 80113
    United States

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  • Trumbill, Connecticut 06611
    United States

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  • Boynton Beach, Florida 33472
    United States

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  • Miami, Florida 33143
    United States

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  • Plant City, Florida 33563
    United States

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  • Tampa, Florida 33607
    United States

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  • Winter Haven, Florida 33880
    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, Indiana 83646
    United States

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  • Elizabethtown, Kentucky 42701
    United States

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  • Lexington, Kentucky 40504
    United States

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  • Metairie, Louisiana 70006
    United States

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  • Traverse City, Michigan 49684
    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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  • Albuquerque, New Mexico 87106
    United States

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  • Brooklyn, New York 11201
    United States

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    Hartsdale, New York 10530
    United States

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  • New Windsor, New York 12553
    United States

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  • New York, New York 10016
    United States

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  • Hickory, North Carolina 28602
    United States

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  • Raleigh, North Carolina 27612
    United States

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  • Winston Salem, North Carolina 27103
    United States

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  • Fargo, North Dakota 58103
    United States

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  • Cincinnati, Ohio 45242
    United States

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  • Middleburg Heights, Ohio 44130
    United States

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  • Perrysburg, Ohio 43551
    United States

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    Norman, Oklahoma 73069
    United States

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  • Jenkintown, Pennsylvania 19046
    United States

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  • Landsdale, Pennsylvania 19446
    United States

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  • Sellersville, Pennsylvania 18960
    United States

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  • Myrtle Beach, South Carolina 29588
    United States

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  • Spartanburg, South Carolina 29303
    United States

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  • Brentwood, Tennessee 37027
    United States

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  • Spring Hill, Tennessee 37174
    United States

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  • Dallas, Texas 75235
    United States

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  • Houston, Texas 77098
    United States

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  • Bountiful, Utah 84010
    United States

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  • West Layton, Utah 84041
    United States

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  • Chesapeake, Virginia 23320
    United States

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  • Richmond, Virginia 23235
    United States

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  • Suffold, Virginia 23435
    United States

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  • Seattle, Washington 98104
    United States

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  • Spokane, Washington 99208
    United States

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  • Morgantown, West Virginia 26505
    United States

    Site Not Available

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