Lesinurad and Allopurinol Combination Extension Study in Gout
A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
2 other identifiers
interventional
717
11 countries
207
Brief Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2013
Typical duration for phase_3
207 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedJanuary 24, 2017
January 1, 2017
3.5 years
March 7, 2013
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with an sUA level that is < 6.0 mg/dL
up to a total of 5 years
Secondary Outcomes (1)
Resolution of at least 1 target tophi
Up to Month 12
Study Arms (2)
lesinurad 200 mg + allopurinol
EXPERIMENTALlesinurad 400 mg + allopurinol
EXPERIMENTALPatients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (207)
Unknown Facility
Birmingham, Alabama, 35213, United States
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Birmingham, Alabama, 35235, United States
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Birmingham, Alabama, 35294, United States
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Gulf Shores, Alabama, 36542, United States
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Pinson, Alabama, 35126, United States
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Glendale, Arizona, 85308, United States
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Mesa, Arizona, 85203, United States
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Peoria, Arizona, 85381, United States
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Little Rock, Arkansas, 72206, United States
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Little Rock, Arkansas, 72211, United States
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Little Rock, Arkansas, 72223, United States
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Anaheim, California, 92805, United States
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Gold River, California, 95670, United States
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Irvine, California, 92618, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95825, United States
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San Diego, California, 92108, United States
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San Leandro, California, 94578, United States
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San Ramon, California, 94582, United States
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Colorado Springs, Colorado, 80918, United States
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Colorado Springs, Colorado, 80922, United States
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Denver, Colorado, 80220, United States
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Englewood, Colorado, 80113, United States
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Brandon, Florida, 33511, United States
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Brooksville, Florida, 34601, United States
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Jacksonville, Florida, 32205, United States
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Jupiter, Florida, 33458, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33169, United States
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Miami, Florida, 33186, United States
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Ocala, Florida, 34474, United States
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Pembroke Pines, Florida, 33027, United States
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Plant City, Florida, 33563, United States
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Port Orange, Florida, 32127, United States
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Tampa, Florida, 33607, United States
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Tampa, Florida, 33634, United States
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Vero Beach, Florida, 32960, United States
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Atlanta, Georgia, 30308, United States
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Atlanta, Georgia, 30328, United States
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Augusta, Georgia, 30909, United States
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Conyers, Georgia, 30013, United States
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Johns Creek, Georgia, 30097, United States
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Roswell, Georgia, 30075, United States
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Savannah, Georgia, 31406, United States
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Honolulu, Hawaii, 96814, United States
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Idaho Falls, Idaho, 83404, United States
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Meridian, Idaho, 83642, United States
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Meridian, Idaho, 83646, United States
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Gurnee, Illinois, 60031, United States
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Cedar Rapids, Iowa, 52403, United States
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Elizabethtown, Kentucky, 42701, United States
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Lexington, Kentucky, 40503, United States
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Paducah, Kentucky, 42003, United States
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Metairie, Louisiana, 70002, United States
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Metairie, Louisiana, 70006, United States
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Natchitoches, Louisiana, 71457, United States
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Cumberland, Maryland, 21502, United States
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Worcester, Massachusetts, 01605, United States
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Ann Arbor, Michigan, 48109, United States
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Flint, Michigan, 48504, United States
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Kalamazoo, Michigan, 49009, United States
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Southfield, Michigan, 48034, United States
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Traverse City, Michigan, 49684, United States
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Hazelwood, Missouri, 63042, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64114, United States
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St Louis, Missouri, 63117, United States
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Washington, Missouri, 63090, United States
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Omaha, Nebraska, 68114, United States
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Reno, Nevada, 89502, 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 York, New York, 10036, United States
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Calabash, North Carolina, 28467, United States
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Charlotte, North Carolina, 28210, United States
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Greensboro, North Carolina, 27405, United States
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Hickory, North Carolina, 28602, United States
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Raleigh, North Carolina, 27609, United States
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Shelby, North Carolina, 28150, United States
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Shelby, North Carolina, 28152, United States
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Wilmington, North Carolina, 28401, 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, 45224, United States
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Cincinnati, Ohio, 45242, United States
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Cleveland, Ohio, 44122, United States
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Colombus, Ohio, 43235, United States
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Dayton, Ohio, 45417, United States
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Dayton, Ohio, 45424, United States
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Franklin, Ohio, 45005, 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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Willoughby Hills, Ohio, 44094, United States
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Oklahoma City, Oklahoma, 73103, United States
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Tulsa, Oklahoma, 74104, United States
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Portland, Oregon, 97220, United States
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Altoona, Pennsylvania, 16602, United States
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Clairton, Pennsylvania, 15025, United States
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Duncansville, Pennsylvania, 16635, United States
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Indiana, Pennsylvania, 15701, United States
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Jenkintown, Pennsylvania, 19046, United States
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McMurray, Pennsylvania, 15317, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Scottdale, Pennsylvania, 15683, United States
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Columbia, South Carolina, 29204, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Myrtle Beach, South Carolina, 29588, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29303, United States
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Union, South Carolina, 29379, United States
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Knoxville, Tennessee, 37919, United States
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Knoxville, Tennessee, 37923, United States
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Memphis, Tennessee, 38119, United States
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Spring Hill, Tennessee, 37174, United States
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Austin, Texas, 78758, United States
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Dallas, Texas, 75218, United States
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Fort Worth, Texas, 76135, United States
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Houston, Texas, 77043, United States
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Houston, Texas, 77062, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77099, United States
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Irving, Texas, 75061, United States
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Kingwood, Texas, 77339, United States
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Nassau Bay, Texas, 77058, United States
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Plano, Texas, 75024, United States
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Plano, Texas, 75075, United States
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San Angelo, Texas, 76904, United States
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San Antonio, Texas, 78209, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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Sealy, Texas, 77474, United States
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Sugar Land, Texas, 77479, United States
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Waco, Texas, 76710, United States
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Bountiful, Utah, 84010, United States
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Layton, Utah, 84041, United States
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Salt Lake City, Utah, 84102, United States
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West Jordan, Utah, 84088, United States
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Danville, Virginia, 24541, United States
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Manassas, Virginia, 20110, United States
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Midlothian, Virginia, 23114, United States
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Richmond, Virginia, 23219, United States
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Richmond, Virginia, 23233, United States
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Richmond, Virginia, 23235, United States
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Virginia Beach, Virginia, 23462, United States
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Olympia, Washington, 98502, United States
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Seattle, Washington, 98104, United States
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Spokane, Washington, 99208, United States
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Tacoma, Washington, 98405, United States
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Morgantown, West Virginia, 26505, United States
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Milwaukee, Wisconsin, 53226, United States
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Herston, Queensland, 4029, Australia
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Clayton, Victoria, 3168, Australia
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Heidelberg West, Victoria, 3081, Australia
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Brisbane, QLD 4152, Australia
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Woodville South, 5011, Australia
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Genk, 3600, Belgium
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Kortrijk, 8500, Belgium
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Lommel, 3920, Belgium
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Yvoir, 5530, Belgium
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Coquitlam, British Columbia, V3K 3P4, Canada
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Penticton, British Columbia, V2A 5C8, Canada
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Kitchener, Ontario, N2M 5N6, Canada
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London, Ontario, N6A 5R8, Canada
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Toronto, Ontario, M9W4L6, Canada
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Québec, Quebec, G1V 3M7, Canada
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Eichstätt, Bavaria, 85072, Germany
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Goch, North Rhine-Westphalia, 47574, Germany
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Dresden, Saxony, 01069, Germany
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Dresden, Saxony, 01307, Germany
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Kamenz, Saxony, 01917, Germany
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Leipzig, Saxony, 04109, Germany
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Grafton, Auckland, 1023, New Zealand
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Otahuhu, Auckland, 2025, New Zealand
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Beckenham, Christchurch, 8024, New Zealand
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Birkinhead, 0626, New Zealand
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Hamilton, 3204, New Zealand
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Rotorua, 3010, New Zealand
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Tauranga, 3143, New Zealand
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Poznan, Greater Poland Voivodeship, 60-773, Poland
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Krakow, Lesser Poland Voivodeship, 30-510, Poland
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Katowice, Silesian Voivodeship, 40-954, Poland
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Warminsko-mazurskie, 82-300, Poland
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Warsaw, 01-192, Poland
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Gmina Końskie, Świętokrzyskie Voivodeship, 26-200, Poland
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Newlands, Durban, 4037, South Africa
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Silverglen, Durban, 4092, South Africa
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Newtown, Johannesburg, 2113, South Africa
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Parktown, Johannesburg, 2193, South Africa
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Radiokop, Johannesburg, 1724, South Africa
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Sowento, Johannesburg, 1804, South Africa
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Thabazimbi, Limpopo, 0380, South Africa
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Muckleneuk, Pretoria, 0002, South Africa
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Durban, 4001, South Africa
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Paarl, 7646, South Africa
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Rondebosch, 7700, South Africa
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Stellenbosch, 7600, South Africa
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Witbank, 1035, South Africa
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Worcester, 6850, South Africa
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Mérida, Badajoz, 06800, Spain
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A Coruña, 15006, Spain
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Lausanne, Canton of Vaud, CH-1011, Switzerland
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Kharkiv, 61157, Ukraine
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Kharkiv, 61176, Ukraine
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Kyiv, 01680, Ukraine
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Poltava, 36011, Ukraine
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Vinnytsia, 21018, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nihar Bhakta, MD
Ardea Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2013
First Posted
March 11, 2013
Study Start
February 1, 2013
Primary Completion
August 1, 2016
Study Completion
November 1, 2016
Last Updated
January 24, 2017
Record last verified: 2017-01