Open-Label Lesinurad Monotherapy Extension Study in Gout
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|ClinicalTrials.gov Identifier: NCT01650246|
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: lesinurad||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: lesinurad 400 mg||
Tablets, 400 mg QD
- Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL [ Time Frame: Month 1 ]
- Incidence of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years ]
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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|
- 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.
- 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
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
|Study Director:||Chris Storgard, MD||Ardea Biosciences, Inc.|
|Responsible Party:||Ardea Biosciences, Inc.|
|Other Study ID Numbers:||
|First Posted:||July 26, 2012 Key Record Dates|
|Results First Posted:||May 26, 2016|
|Last Update Posted:||May 26, 2016|
|Last Verified:||April 2016|
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