Lesinurad and Febuxostat Combination Extension Study in Gout



Status:Completed
Conditions:Gout
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 85
Updated:2/1/2018
Start Date:March 1, 2013
End Date:October 6, 2016

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A Long-Term Extension Study of Lesinurad in Combination With Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat

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

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.

Inclusion Criteria:

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

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

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

Exclusion Criteria:

- Subject has any medical or psychological condition, which in the opinion of the
Investigator and/or the Medical Monitor, might create undue risk to the subject or
interfere with the subject's ability to comply with the protocol requirements, or to
complete the study.
We found this trial at
54
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Seattle, WA
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Ann Arbor, MI
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Austin, TX
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Belle Vernon, Pennsylvania 15812
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Belle Vernon, PA
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Birmingham, AL
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Camperdown,
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Chesapeake, VA
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Columbia, SC
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2004
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Columbus, OH
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Dallas, TX
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Danville, VA
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Denver, CO
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Elizabethtown, KY
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Englewood, CO
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1172
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Fargo, ND
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Frederick, MD
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955
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Glendale, CA
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Gurnee, IL
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Honolulu, HI
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Houston, TX
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Huntington Beach, California 92646
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995
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Irvine, CA
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1983
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Jackson, MS
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Jefferson City, MO
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Johns Creek, GA
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Lansdale, PA
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Memphis, TN
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399
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Meridian, ID
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2019
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Middleburg Heights, OH
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Morgantown, WV
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Naples, FL
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2400
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New York, NY
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1523
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Oklahoma City, OK
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Olive Branch, Mississippi 38654
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Pembroke Pines, FL
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Pittsburgh, PA
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Richmond, VA
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Saint Louis, MO
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San Antonio, TX
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San Diego, CA
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Sellersville, Pennsylvania 18960
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Sellersville, PA
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Southfield, MI
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Spartanburg, South Carolina 29303
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Springfield, IL
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Sugar Land, TX
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Tampa, FL
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Tempe, AZ
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Victoria, TX
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Waco, TX
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Wadsworth, OH
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Wilmington, North Carolina 28401
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Winter Haven, FL
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