Lesinurad and Allopurinol Combination Extension Study in Gout



Status:Completed
Conditions:Gout
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 85
Updated:10/14/2017
Start Date:February 2013
End Date:November 2016

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

This study will assess the serum uric acid lowering effects and safety of lesinurad in
combination with allopurinol 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 allopurinol in subjects who completed the double-blind treatment period in
Studies RDEA594-301 and RDEA594-302.

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 either Study RDEA594-301 or
RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or
placebo) and allopurinol 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

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.
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130
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Kingwood, TX
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Albuquerque, NM
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Anaheim, CA
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Austin, TX
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Brooklyn, NY
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Calabash, NC
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Cedar Rapids, IA
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Charlotte, North Carolina 28207
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Charlotte, NC
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Clairton, PA
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Cleveland, OH
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420 West 12th Avenue
Colombus, Ohio 43210
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Colorado Springs, Colorado 80910
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Denver, CO
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Duncansville, Pennsylvania 16635
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Elizabethtown, KY
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Fargo, ND
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Flint, MI
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Fort Worth, TX
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Franklin, Ohio 43210
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Greensboro, North Carolina 27401
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Gulf Shores, AL
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Gurnee, IL
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Hartsdale, NY
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Hazelwood, MO
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Herston,
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Honolulu, HI
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Houston, TX
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Morgantown, WV
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Mount Pleasant, South Carolina 29464
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Myrtle Beach, South Carolina 29572
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