Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Drug Reactions
研究概览
简要总结
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs.
For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with SRI or MiRI undergoing orthopedic surgery of the lower limbs
排除标准
- •Patients who are on hemodialysis or are scheduled to undergo hemodialysis during the study period
- •Patients who are at a significantly high risk for bleeding or thromboembolism
- •Patients who are receiving another antithrombotic therapy and are unable to suspend the therapy
- •Patients who have evidence of hepatic function test abnormalities
研究组 & 干预措施
SRI 15mg (15 mL/min ≤ CLCR < 20mL/min)
Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
干预措施: 15mg DU-176b (Drug)
MiRI 30mg (50 mL/min ≤ CLCR ≤ 80mL/min)
Mild Renal Impairment group orally administered 30mg DU-176b once daily for 14 days.
干预措施: 30mg DU-176b (Drug)
Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)
Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.
干预措施: Fondaparinux (Drug)
SRI 15mg (20 mL/min ≤ CLCR < 30mL/min)
Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
干预措施: 15mg DU-176b (Drug)
结局指标
主要结局
Incidence of Adverse Drug Reactions
时间窗: 1 month
Plasma Concentration of DU-176b
时间窗: 14 days
Plasma Concentration of D21-2393
时间窗: 14 days
Incidence of Any Adjudicated Bleeding Events
时间窗: 14 days
Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).
Incidence of Adverse Events
时间窗: 1 month
次要结局
- Incidence of Adjudicated Thromboembolic Events(1 month)