Phase 3
N=143
Open-Label Lesinurad Monotherapy Extension Study in Gout
Gout
Bottom Line
View on ClinicalTrials.gov: NCT01650246 ↗Enrolled (actual)
143
Serious AEs
10.5%
Results posted
May 2016
Primary outcome: Primary: Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL — 68 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- lesinurad (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ardea Biosciences, Inc.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL |
68 | — |
| PRIMARY Incidence of Treatment-emergent Adverse Events (TEAEs) |
105 | — |
Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.
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 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
Data sourced from ClinicalTrials.gov (NCT01650246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.