NCT01650246已完成3 期
A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 主要终点
- Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
研究概览
简要总结
This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
lesinurad 400 mg
Experimental
干预措施: lesinurad (Drug)
结局指标
主要结局
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
时间窗: Month 1
Incidence of Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to approximately 2 years
次要结局
未报告次要终点
研究者
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