Clinical trial NCT01808144: Lesinurad and Febuxostat Combination Extension Study in Gout
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Keywords: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With an sUA Level That is < 5.0 mg/dL
timeFrame: Up to approximately 2.5 years (at Extension Month 12)
Secondary outcomes:
measure: Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
timeFrame: Up to approximatley 2.5 years (at Extension Month 12)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tempe
country: United States
state: Arizona
city: Glendale
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Irvine
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Johns Creek
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Meridian
country: United States
state: Idaho
city: Gurnee
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Elizabethtown
country: United States
state: Kentucky
city: Frederick
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Olive Branch
country: United States
state: Mississippi
city: Jefferson City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Wilmington
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Columbus
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Wadsworth
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Belle Vernon
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Victoria
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Danville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Camperdown
country: Australia
state: New South Wales
city: Woodville South
country: Australia
state: South Australia
city: Hobart
country: Australia
state: Tasmania
city: Mississauga
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Grafton
country: New Zealand
state: Auckland
city: Tauranga
country: New Zealand
city: Kutno
country: Poland
state: Iodzkie
city: Krakow
country: Poland
state: Malopolskie
city: Krakow
country: Poland
state: Malopolskie
city: Bialystok
country: Poland
state: Podlaskie
city: Katowice
country: Poland
state: Slaskie
city: Konskie
country: Poland
state: Swietokrzyskie
city: Elblag
country: Poland
state: Warminsko-Mazurskie
city: Poznan
country: Poland
state: Wielkopolskie
city: Fribourg
country: Switzerland
city: Fribourg
country: Switzerland
Study officials:
affiliation: Ardea Biosciences, Inc.
name: Nihar Bhakta, MD
role: STUDY_DIRECTOR
References: