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Lesinurad and Allopurinol Combination Extension Study in Gout

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01808131
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : January 24, 2017
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 allopurinol over a long-term timeframe.

Condition or disease Intervention/treatment Phase
Gout Drug: Lesinurad Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 717 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 Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
Study Start Date : February 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 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 200 mg + allopurinol Drug: Lesinurad
Tablets, 200 mg QD

Experimental: lesinurad 400 mg + allopurinol
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Drug: Lesinurad
Tablets, 400 mg QD




Primary Outcome Measures :
  1. Proportion of subjects with an sUA level that is < 6.0 mg/dL [ Time Frame: up to a total of 5 years ]

Secondary Outcome Measures :
  1. Resolution of at least 1 target tophi [ Time Frame: Up to Month 12 ]


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 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.

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): NCT01808131


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35213
Birmingham, Alabama, United States, 35235
Birmingham, Alabama, United States, 35294
Gulf Shores, Alabama, United States, 36542
Pinson, Alabama, United States, 35126
United States, Arizona
Glendale, Arizona, United States, 85308
Mesa, Arizona, United States, 85203
Peoria, Arizona, United States, 85381
United States, Arkansas
Little Rock, Arkansas, United States, 72206
Little Rock, Arkansas, United States, 72211
Little Rock, Arkansas, United States, 72223
United States, California
Anaheim, California, United States, 92805
Gold River, California, United States, 95670
Irvine, California, United States, 92618
Roseville, California, United States, 95661
Sacramento, California, United States, 95825
San Diego, California, United States, 92108
San Leandro, California, United States, 94578
San Ramon, California, United States, 94582
United States, Colorado
Colorado Springs, Colorado, United States, 80918
Colorado Springs, Colorado, United States, 80922
Denver, Colorado, United States, 80220
Englewood, Colorado, United States, 80113
United States, Florida
Brandon, Florida, United States, 33511
Brooksville, Florida, United States, 34601
Jacksonville, Florida, United States, 32205
Jupiter, Florida, United States, 33458
Miami, Florida, United States, 33125
Miami, Florida, United States, 33169
Miami, Florida, United States, 33186
Ocala, Florida, United States, 34474
Pembroke Pines, Florida, United States, 33027
Plant City, Florida, United States, 33563
Port Orange, Florida, United States, 32127
Tampa, Florida, United States, 33607
Tampa, Florida, United States, 33634
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30328
Augusta, Georgia, United States, 30909
Conyers, Georgia, United States, 30013
Johns Creek, Georgia, United States, 30097
Roswell, Georgia, United States, 30075
Savannah, Georgia, United States, 31406
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Idaho
Idaho Falls, Idaho, United States, 83404
Meridian, Idaho, United States, 83642
Meridian, Idaho, United States, 83646
United States, Illinois
Gurnee, Illinois, United States, 60031
United States, Iowa
Cedar Rapids, Iowa, United States, 52403
United States, Kentucky
Elizabethtown, Kentucky, United States, 42701
Lexington, Kentucky, United States, 40503
Paducah, Kentucky, United States, 42003
United States, Louisiana
Metairie, Louisiana, United States, 70002
Metairie, Louisiana, United States, 70006
Natchitoches, Louisiana, United States, 71457
United States, Maryland
Cumberland, Maryland, United States, 21502
United States, Massachusetts
Worcester, Massachusetts, United States, 01605
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Flint, Michigan, United States, 48504
Kalamazoo, Michigan, United States, 49009
Southfield, Michigan, United States, 48034
Traverse City, Michigan, United States, 49684
United States, Missouri
Hazelwood, Missouri, United States, 63042
Jefferson City, Missouri, United States, 65109
Kansas City, Missouri, United States, 64114
Saint Louis, Missouri, United States, 63117
St. Louis, Missouri, United States, 63117
Washington, Missouri, United States, 63090
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, Nevada
Reno, Nevada, United States, 89502
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Brooklyn, New York, United States, 11201
Hartsdale, New York, United States, 10530
New York, New York, United States, 10036
United States, North Carolina
Calabash, North Carolina, United States, 28467
Charlotte, North Carolina, United States, 28210
Greensboro, North Carolina, United States, 27405
Hickory, North Carolina, United States, 28602
Raleigh, North Carolina, United States, 27609
Shelby, North Carolina, United States, 28150
Shelby, North Carolina, United States, 28152
Wilmington, North Carolina, United States, 28401
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cincinnati, Ohio, United States, 45224
Cincinnati, Ohio, United States, 45242
Cleveland, Ohio, United States, 44122
Colombus, Ohio, United States, 43235
Dayton, Ohio, United States, 45417
Dayton, Ohio, United States, 45424
Franklin, Ohio, United States, 45005
Middleburg Heights, Ohio, United States, 44130
Perrysburg, Ohio, United States, 43551
Willoughby Hills, Ohio, United States, 44094
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Portland, Oregon, United States, 97220
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
Clairton, Pennsylvania, United States, 15025
Duncansville, Pennsylvania, United States, 16635
Indiana, Pennsylvania, United States, 15701
Jenkintown, Pennsylvania, United States, 19046
McMurray, Pennsylvania, United States, 15317
Pittsburgh, Pennsylvania, United States, 15206
Scottdale, Pennsylvania, United States, 15683
United States, South Carolina
Columbia, South Carolina, United States, 29204
Mount Pleasant, South Carolina, United States, 29464
Myrtle Beach, South Carolina, United States, 29588
Rock Hill, South Carolina, United States, 29732
Spartanburg, South Carolina, United States, 29303
Union, South Carolina, United States, 29379
United States, Tennessee
Knoxville, Tennessee, United States, 37919
Knoxville, Tennessee, United States, 37923
Memphis, Tennessee, United States, 38119
Spring Hill, Tennessee, United States, 37174
United States, Texas
Austin, Texas, United States, 78758
Dallas, Texas, United States, 75218
Fort Worth, Texas, United States, 76135
Houston, Texas, United States, 77043
Houston, Texas, United States, 77062
Houston, Texas, United States, 77074
Houston, Texas, United States, 77099
Irving, Texas, United States, 75061
Kingwood, Texas, United States, 77339
Nassau Bay, Texas, United States, 77058
Plano, Texas, United States, 75024
Plano, Texas, United States, 75075
San Angelo, Texas, United States, 76904
San Antonio, Texas, United States, 78209
San Antonio, Texas, United States, 78215
San Antonio, Texas, United States, 78229
Sealy, Texas, United States, 77474
Sugar Land, Texas, United States, 77479
Waco, Texas, United States, 76710
United States, Utah
Bountiful, Utah, United States, 84010
Layton, Utah, United States, 84041
Salt Lake City, Utah, United States, 84102
West Jordan, Utah, United States, 84088
United States, Virginia
Danville, Virginia, United States, 24541
Manassas, Virginia, United States, 20110
Midlothian, Virginia, United States, 23114
Richmond, Virginia, United States, 23219
Richmond, Virginia, United States, 23233
Richmond, Virginia, United States, 23235
Virginia Beach, Virginia, United States, 23462
United States, Washington
Olympia, Washington, United States, 98502
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99208
Tacoma, Washington, United States, 98405
United States, West Virginia
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, Queensland
Herston, Queensland, Australia, 4029
Australia, Victoria
Clayton, Victoria, Australia, 3168
Heidelberg West, Victoria, Australia, 3081
Australia
Brisbane, Australia, QLD 4152
Woodville South, Australia, 5011
Belgium
Genk, Belgium, 3600
Kortrijk, Belgium, 8500
Lommel, Belgium, 3920
Yvoir, Belgium, 5530
Canada, British Columbia
Coquitlam, British Columbia, Canada, V3K 3P4
Penticton, British Columbia, Canada, V2A 5C8
Canada, Ontario
Kitchener, Ontario, Canada, N2M 5N6
London, Ontario, Canada, N6A 5R8
Toronto, Ontario, Canada, M9W4L6
Canada, Quebec
Québec City, Quebec, Canada, G1V 3M7
Germany
Eichstätt, Bayern, Germany, 85072
Goch, Nordrhein-Westfalen, Germany, 47574
Dresden, Sachsen, Germany, 01069
Dresden, Sachsen, Germany, 01307
Kamenz, Sachsen, Germany, 01917
Leipzig, Sachsen, Germany, 04109
New Zealand
Grafton, Auckland, New Zealand, 1023
Otahuhu, Auckland, New Zealand, 2025
Beckenham, Christchurch, New Zealand, 8024
Birkinhead, New Zealand, 0626
Hamilton, New Zealand, 3204
Rotorua, New Zealand, 3010
Tauranga, New Zealand, 3143
Poland
Krakow, Malopolskie, Poland, 30-510
Katowice, Slaskie, Poland, 40-954
Konskie, Swietokrzyskie, Poland, 26-200
Poznan, Wielkopolskie, Poland, 60-773
Warminsko-mazurskie, Poland, 82-300
Warszawa, Poland, 01-192
South Africa
Newlands, Durban, South Africa, 4037
Silverglen, Durban, South Africa, 4092
Newtown, Johannesburg, South Africa, 2113
Parktown, Johannesburg, South Africa, 2193
Radiokop, Johannesburg, South Africa, 1724
Sowento, Johannesburg, South Africa, 1804
Thabazimbi, Limpopo, South Africa, 0380
Muckleneuk, Pretoria, South Africa, 0002
Durban, South Africa, 4001
Paarl, South Africa, 7646
Rondebosch, South Africa, 7700
Stellenbosch, South Africa, 7600
Witbank, South Africa, 1035
Worcester, South Africa, 6850
Spain
Merida, Badajoz, Spain, 06800
La Coruna, Spain, 15006
Switzerland
Lausanne, Vaud, Switzerland, CH-1011
Ukraine
Kharkiv, Ukraine, 61157
Kharkiv, Ukraine, 61176
Kyiv, Ukraine, 01680
Poltava, Ukraine, 36011
Vinnytsia, Ukraine, 21018
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: NCT01808131     History of Changes
Other Study ID Numbers: RDEA594-306
2012-004389-16 ( EudraCT Number )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
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
Allopurinol
Lesinurad
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Uricosuric Agents
Renal Agents