Lesinurad and Febuxostat Combination Extension Study in Gout
NCT ID: NCT01808144
Last Updated: 2018-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
196 participants
INTERVENTIONAL
2013-03-01
2016-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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lesinurad 400 mg + febuxostat 80 mg
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
lesinurad
Tablets, 400 mg once daily (QD)
febuxostat
Tabletsm 80 mg QD
lesinurad 200 mg + febuxostat 80 mg
lesinurad
Tablets, 200 mg QD
febuxostat
Tabletsm 80 mg QD
Interventions
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lesinurad
Tablets, 400 mg once daily (QD)
lesinurad
Tablets, 200 mg QD
febuxostat
Tabletsm 80 mg QD
Eligibility Criteria
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Inclusion Criteria
* 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
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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Nihar Bhakta, MD
Role: STUDY_DIRECTOR
Ardea Biosciences, Inc.
Locations
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Birmingham, Alabama, United States
Tempe, Arizona, United States
Glendale, California, United States
Huntington Beach, California, United States
Irvine, California, United States
San Diego, California, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Boynton Beach, Florida, United States
Naples, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Johns Creek, Georgia, United States
Honolulu, Hawaii, United States
Meridian, Idaho, United States
Gurnee, Illinois, United States
Springfield, Illinois, United States
Elizabethtown, Kentucky, United States
Frederick, Maryland, United States
Ann Arbor, Michigan, United States
Southfield, Michigan, United States
Jackson, Mississippi, United States
Olive Branch, Mississippi, United States
Jefferson City, Missouri, United States
St Louis, Missouri, United States
New York, New York, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Middleburg Heights, Ohio, United States
Wadsworth, Ohio, United States
Oklahoma City, Oklahoma, United States
Belle Vernon, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Columbia, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Spartanburg, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Victoria, Texas, United States
Waco, Texas, United States
Chesapeake, Virginia, United States
Danville, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Camperdown, New South Wales, Australia
Woodville South, South Australia, Australia
Hobart, Tasmania, Australia
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Grafton, Auckland, New Zealand
Tauranga, , New Zealand
Poznan, Greater Poland Voivodeship, Poland
Kutno, Iodzkie, Poland
Krakow, Lesser Poland Voivodeship, Poland
Krakow, Lesser Poland Voivodeship, Poland
Bialystok, Podlaskie Voivodeship, Poland
Katowice, Silesian Voivodeship, Poland
Elblag, Warmian-Masurian Voivodeship, Poland
Gmina Końskie, Świętokrzyskie Voivodeship, Poland
Fribourg, , Switzerland
Fribourg, , Switzerland
Countries
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Other Identifiers
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2012-004390-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RDEA594-307
Identifier Type: -
Identifier Source: org_study_id
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