Clinical trial NCT01808131: Lesinurad and Allopurinol Combination Extension Study in Gout
Official title: A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
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: 717
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 allopurinol 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 allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.

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 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.

Primary outcomes:
measure: Proportion of subjects with an sUA level that is < 6.0 mg/dL
timeFrame: up to a total of 5 years
Secondary outcomes:
measure: Resolution of at least 1 target tophi
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Gulf Shores
country: United States
state: Alabama
city: Pinson
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Gold River
country: United States
state: California
city: Irvine
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Leandro
country: United States
state: California
city: San Ramon
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Brandon
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Plant City
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Johns Creek
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Idaho Falls
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Gurnee
country: United States
state: Illinois
city: Cedar Rapids
country: United States
state: Iowa
city: Elizabethtown
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Natchitoches
country: United States
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Hazelwood
country: United States
state: Missouri
city: Jefferson City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Hartsdale
country: United States
state: New York
city: New York
country: United States
state: New York
city: Calabash
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Shelby
country: United States
state: North Carolina
city: Shelby
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Colombus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Willoughby Hills
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Clairton
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Indiana
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: McMurray
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Scottdale
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Union
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Spring Hill
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Kingwood
country: United States
state: Texas
city: Nassau Bay
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sealy
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Layton
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Danville
country: United States
state: Virginia
city: Manassas
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Herston
country: Australia
state: Queensland
city: Clayton
country: Australia
state: Victoria
city: Heidelberg West
country: Australia
state: Victoria
city: Brisbane
country: Australia
city: Woodville South
country: Australia
city: Genk
country: Belgium
city: Kortrijk
country: Belgium
city: Lommel
country: Belgium
city: Yvoir
country: Belgium
city: Coquitlam
country: Canada
state: British Columbia
city: Penticton
country: Canada
state: British Columbia
city: Kitchener
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Québec City
country: Canada
state: Quebec
city: Eichstätt
country: Germany
state: Bayern
city: Goch
country: Germany
state: Nordrhein-Westfalen
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Kamenz
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Grafton
country: New Zealand
state: Auckland
city: Otahuhu
country: New Zealand
state: Auckland
city: Beckenham
country: New Zealand
state: Christchurch
city: Birkinhead
country: New Zealand
city: Hamilton
country: New Zealand
city: Rotorua
country: New Zealand
city: Tauranga
country: New Zealand
city: Krakow
country: Poland
state: Malopolskie
city: Katowice
country: Poland
state: Slaskie
city: Konskie
country: Poland
state: Swietokrzyskie
city: Poznan
country: Poland
state: Wielkopolskie
city: Warminsko-mazurskie
country: Poland
city: Warszawa
country: Poland
city: Newlands
country: South Africa
state: Durban
city: Silverglen
country: South Africa
state: Durban
city: Newtown
country: South Africa
state: Johannesburg
city: Parktown
country: South Africa
state: Johannesburg
city: Radiokop
country: South Africa
state: Johannesburg
city: Sowento
country: South Africa
state: Johannesburg
city: Thabazimbi
country: South Africa
state: Limpopo
city: Muckleneuk
country: South Africa
state: Pretoria
city: Durban
country: South Africa
city: Paarl
country: South Africa
city: Rondebosch
country: South Africa
city: Stellenbosch
country: South Africa
city: Witbank
country: South Africa
city: Worcester
country: South Africa
city: Merida
country: Spain
state: Badajoz
city: La Coruna
country: Spain
city: Lausanne
country: Switzerland
state: Vaud
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Poltava
country: Ukraine
city: Vinnytsia
country: Ukraine
Study officials:
affiliation: Ardea Biosciences, Inc.
name: Nihar Bhakta, MD
role: STUDY_DIRECTOR
References: