A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- Prevention of Venous Thromboembolism (VTE)
研究概览
简要总结
Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.
详细描述
The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral hip replacement
排除标准
- •Patients scheduled for bilateral hip replacement in same procedure
- •Patients with increased risk of bleeding
- •Uncontrolled hypertension (BP greater than 180/100 mmHg)
- •Patients less than 111 lbs or more than 243 lbs
- •Patients on long-term anticoagulants
- •Patients with contraindications to venography
- •Patients with medical history of venous thromboembolism
- •Patients with impaired hepatic function
- •Known to be pregnant
- •Lactating women
研究组 & 干预措施
15mg BID
15mg edoxaban administered twice daily (BID)
干预措施: DU-176b (Drug)
30mg QD
30mg edoxaban administered once daily (QD)
干预措施: DU-176b (Drug)
30mg BID
30mg edoxaban administered twice daily (BID)
干预措施: DU-176b (Drug)
60mg QD
60mg edoxaban administered once daily (QD)
干预措施: DU-176b (Drug)
60mg BID
60mg edoxaban administered twice daily (BID)
干预措施: DU-176b (Drug)
120mg QD
120mg edoxaban administered once daily (QD)
干预措施: DU-176b (Drug)
结局指标
主要结局
Prevention of Venous Thromboembolism (VTE)
时间窗: 2 weeks
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery). Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography
次要结局
- Change From Baseline for Prothrombin Time (PT) Results(end of treatment)
- Change From Baseline for International Normalized Ratio (INR) Results(end of treatment)
- Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results(end of treatment)