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Lesinurad and Febuxostat Combination Extension Study in Gout

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ClinicalTrials.gov Identifier: NCT01808144
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Gout Drug: lesinurad Drug: febuxostat Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2013
Actual Primary Completion Date : August 9, 2016
Actual Study Completion Date : October 6, 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: 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.
Drug: lesinurad
Tablets, 400 mg once daily (QD)

Drug: febuxostat
Tabletsm 80 mg QD

Experimental: lesinurad 200 mg + febuxostat 80 mg Drug: lesinurad
Tablets, 200 mg QD

Drug: febuxostat
Tabletsm 80 mg QD




Primary Outcome Measures :
  1. Percentage of Participants With an sUA Level That is < 5.0 mg/dL [ Time Frame: Up to approximately 2.5 years (at Extension Month 12) ]
    Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases


Secondary Outcome Measures :
  1. Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus [ Time Frame: Up to approximatley 2.5 years (at Extension Month 12) ]
    Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808144


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35211
United States, Arizona
Tempe, Arizona, United States, 85282
United States, California
Glendale, California, United States, 91204
Huntington Beach, California, United States, 92646
Irvine, California, United States, 92618
San Diego, California, United States, 92108
United States, Colorado
Denver, Colorado, United States, 80220
Englewood, Colorado, United States, 80113
United States, Florida
Boynton Beach, Florida, United States, 33472
Naples, Florida, United States, 34102
Pembroke Pines, Florida, United States, 33027
Tampa, Florida, United States, 33606
Tampa, Florida, United States, 33614
Winter Haven, Florida, United States, 33880
United States, Georgia
Johns Creek, Georgia, United States, 30097
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Idaho
Meridian, Idaho, United States, 83646
United States, Illinois
Gurnee, Illinois, United States, 60031
Springfield, Illinois, United States, 62704
United States, Kentucky
Elizabethtown, Kentucky, United States, 42701
United States, Maryland
Frederick, Maryland, United States, 21702
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Southfield, Michigan, United States, 48034
United States, Mississippi
Jackson, Mississippi, United States, 39202
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Jefferson City, Missouri, United States, 65109
Saint Louis, Missouri, United States, 63117
United States, New York
New York, New York, United States, 10036
United States, North Carolina
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Columbus, Ohio, United States, 43203
Middleburg Heights, Ohio, United States, 44130
Wadsworth, Ohio, United States, 44281
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Belle Vernon, Pennsylvania, United States, 15012
Lansdale, Pennsylvania, United States, 19446
Pittsburgh, Pennsylvania, United States, 15206
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Columbia, South Carolina, United States, 29204
Mount Pleasant, South Carolina, United States, 29464
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Austin, Texas, United States, 78705
Austin, Texas, United States, 78758
Dallas, Texas, United States, 75218
Houston, Texas, United States, 77074
San Antonio, Texas, United States, 78229
Sugar Land, Texas, United States, 77479
Victoria, Texas, United States, 77901
Waco, Texas, United States, 76710
United States, Virginia
Chesapeake, Virginia, United States, 23320
Danville, Virginia, United States, 24541
Richmond, Virginia, United States, 23235
United States, Washington
Seattle, Washington, United States, 98104
United States, West Virginia
Morgantown, West Virginia, United States, 26505
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Woodville South, South Australia, Australia, 5011
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Canada, Ontario
Mississauga, Ontario, Canada, L5M 2V8
Toronto, Ontario, Canada, M9W4L6
New Zealand
Grafton, Auckland, New Zealand, 1023
Tauranga, New Zealand, 3143
Poland
Kutno, Iodzkie, Poland, 99-300
Krakow, Malopolskie, Poland, 30-510
Krakow, Malopolskie, Poland, 31-501
Bialystok, Podlaskie, Poland, 15-430
Katowice, Slaskie, Poland, 40-954
Konskie, Swietokrzyskie, Poland, 26-200
Elblag, Warminsko-Mazurskie, Poland, 82-300
Poznan, Wielkopolskie, Poland, 60-773
Switzerland
Fribourg, Switzerland, 1705
Fribourg, Switzerland, 1708
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: Nihar Bhakta, MD Ardea Biosciences, Inc.

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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01808144     History of Changes
Other Study ID Numbers: RDEA594-307
2012-004390-54 ( EudraCT Number )
First Posted: March 11, 2013    Key Record Dates
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018
Last Verified: January 2018
Keywords provided by Ardea Biosciences, Inc.:
Gout
Additional relevant MeSH terms:
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Gout
Gout Suppressants
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Febuxostat
Lesinurad
Antirheumatic Agents
Uricosuric Agents
Renal Agents