A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg Versus Placebo and Open-Label Allopurinol 200 mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Percent Changes of Serum Uric Acid Levels From Baseline Levels
研究概览
简要总结
This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:
- •sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;
- •sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);
- •sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications.
排除标准
- •Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit.
- •Subject has a history or suspicion of kidney stones.
- •Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft Gault formula
- •Subject is receiving strong or moderate CYP3A inhibitors
研究组 & 干预措施
RDEA3170 1
RDEA3170 5mg followed by RDEA3170 7.5mg
干预措施: RDEA3170 (Drug)
RDEA3170 2
RDEA3170 10mg followed by RDEA3170 12.5mg
干预措施: RDEA3170 (Drug)
RDEA3170 3
RDEA3170 12.5mg followed by RDEA3170 15mg
干预措施: RDEA3170 (Drug)
RDEA3170 4
RDEA3170 Placebo
干预措施: Placebo (Drug)
Allopurinol
Allopurinol 200mg
干预措施: Allopurinol (Drug)
结局指标
主要结局
Percent Changes of Serum Uric Acid Levels From Baseline Levels
时间窗: Baseline and Week 16
The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.
次要结局
- Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL(Weeks 1,2,4,6,8,10,12,16,18,20,24)
- Absolute Change of Serum Uric Acid Levels From Baseline Levels(Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24)
- Percent Change in sUA(Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24)