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Open-Label Lesinurad Monotherapy 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: NCT01650246
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
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 over a long-term timeframe.

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

Detailed Description:
This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout
Study Start Date : August 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Lesinurad

Arm Intervention/treatment
Experimental: lesinurad 400 mg Drug: lesinurad
Tablets, 400 mg QD




Primary Outcome Measures :
  1. Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL [ Time Frame: Month 1 ]
  2. Incidence of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years ]


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 RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
  • Subject is willing to adhere to the visit/protocol schedules.
  • 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 other 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.
  • Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
  • Subject developed kidney stones during Study RDEA594-303

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): NCT01650246


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35209
Birmingham, Alabama, United States, 35211
Birmingham, Alabama, United States, 35294
United States, Arizona
Glendale, Arizona, United States, 85308
Peoria, Arizona, United States, 85381
Tempe, Arizona, United States, 85282
United States, California
Carmichael, California, United States, 95608
Covina, California, United States, 91723
Huntington Park, California, United States, 90255
Irvine, California, United States, 92618
United States, Colorado
Colorado Springs, Colorado, United States, 80922
Denver, Colorado, United States, 80220
Denver, Colorado, United States, 80230
Englewood, Colorado, United States, 80113
United States, Connecticut
Trumbill, Connecticut, United States, 06611
United States, Florida
Boynton Beach, Florida, United States, 33472
Miami, Florida, United States, 33143
Plant City, Florida, United States, 33563
Tampa, Florida, United States, 33607
Winter Haven, Florida, United States, 33880
United States, Georgia
Newnan, Georgia, United States, 30265
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Indiana
Meridian, Indiana, United States, 83646
United States, Kentucky
Elizabethtown, Kentucky, United States, 42701
Lexington, Kentucky, United States, 40504
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Michigan
Traverse City, Michigan, United States, 49684
United States, Mississippi
Jackson, Mississippi, United States, 39202
Olive Branch, Mississippi, United States, 38654
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Brooklyn, New York, United States, 11201
New Windsor, New York, United States, 12553
New York, New York, United States, 10016
United States, North Carolina
Hickory, North Carolina, United States, 28602
Raleigh, North Carolina, United States, 27612
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cincinnati, Ohio, United States, 45242
Middleburg Heights, Ohio, United States, 44130
Perrysburg, Ohio, United States, 43551
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Landsdale, Pennsylvania, United States, 19446
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Myrtle Beach, South Carolina, United States, 29588
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Brentwood, Tennessee, United States, 37027
Spring Hill, Tennessee, United States, 37174
United States, Texas
Dallas, Texas, United States, 75235
Houston, Texas, United States, 77098
United States, Utah
Bountiful, Utah, United States, 84010
West Layton, Utah, United States, 84041
United States, Virginia
Chesapeake, Virginia, United States, 23320
Richmond, Virginia, United States, 23235
Suffold, Virginia, United States, 23435
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99208
United States, West Virginia
Morgantown, West Virginia, United States, 26505
Australia, Queensland
Herston, Queensland, Australia, 4029
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Belgium
Genk, Belgium, 3600
Gozée, Belgium, 6534
Kortrijk, Belgium, 8500
Yvoir, Belgium, 5530
Canada, Ontario
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Rimouski, Quebec, Canada, G5L 8W1
Canada
Quebec, Canada, G1V 3M7
Germany
Dresden, Germany, 01069
Leipzig, Germany, 04109
New Zealand
Grafton, Auckland, New Zealand, 1023
Tauranga, New Zealand, 3143
South Africa
Silverglen, Durban, South Africa, 4092
Muckleneuk, Pretoria, South Africa, 0002
Rondebosch, South Africa, 7700
Stellenbosch, South Africa, 7600
Thabazimbi, South Africa, 0380
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: Chris Storgard, MD Ardea Biosciences, Inc.

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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01650246     History of Changes
Other Study ID Numbers: RDEA594-305
First Posted: July 26, 2012    Key Record Dates
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016
Last Verified: April 2016
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
Lesinurad
Antirheumatic Agents
Uricosuric Agents
Renal Agents