Open-Label Lesinurad Monotherapy Extension Study in Gout
NCT ID: NCT01650246
Last Updated: 2016-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
143 participants
INTERVENTIONAL
2012-08-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lesinurad 400 mg
lesinurad
Tablets, 400 mg QD
Interventions
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lesinurad
Tablets, 400 mg QD
Eligibility Criteria
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Inclusion Criteria
* Subject completed the double-blind treatment period in Study RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
* Subject is willing to adhere to the visit/protocol schedules.
* 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 a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
* Subject developed kidney stones during Study RDEA594-303
18 Years
85 Years
ALL
No
Sponsors
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Ardea Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Storgard, MD
Role: STUDY_DIRECTOR
Ardea Biosciences, Inc.
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Glendale, Arizona, United States
Peoria, Arizona, United States
Tempe, Arizona, United States
Carmichael, California, United States
Covina, California, United States
Huntington Park, California, United States
Irvine, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Trumbill, Connecticut, United States
Boynton Beach, Florida, United States
Miami, Florida, United States
Plant City, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Newnan, Georgia, United States
Honolulu, Hawaii, United States
Meridian, Indiana, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
Metairie, Louisiana, United States
Traverse City, Michigan, United States
Jackson, Mississippi, United States
Olive Branch, Mississippi, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
New Windsor, New York, United States
New York, New York, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
Perrysburg, Ohio, United States
Jenkintown, Pennsylvania, United States
Landsdale, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Spartanburg, South Carolina, United States
Brentwood, Tennessee, United States
Spring Hill, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Bountiful, Utah, United States
West Layton, Utah, United States
Chesapeake, Virginia, United States
Richmond, Virginia, United States
Suffold, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Morgantown, West Virginia, United States
Herston, Queensland, Australia
Hobart, Tasmania, Australia
Genk, , Belgium
Gozée, , Belgium
Kortrijk, , Belgium
Yvoir, , Belgium
Toronto, Ontario, Canada
Québec, Quebec, Canada
Rimouski, Quebec, Canada
Dresden, , Germany
Leipzig, , Germany
Grafton, Auckland, New Zealand
Tauranga, , New Zealand
Silverglen, Durban, South Africa
Muckleneuk, Pretoria, South Africa
Rondebosch, , South Africa
Stellenbosch, , South Africa
Thabazimbi, , South Africa
Countries
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Other Identifiers
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RDEA594-305
Identifier Type: -
Identifier Source: org_study_id
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