A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,238
- 试验地点
- 1
- 主要终点
- Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery
研究概览
简要总结
The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective unilateral total knee replacement surgery.
- •Willing and able to undergo bilateral ascending contrast venography.
- •Able to inject (by self or caregiver) study medication subcutaneously.
排除标准
- •Women of childbearing potential.
- •Women who are pregnant or breastfeeding.
- •Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) >=35 kg/m2
研究组 & 干预措施
A1
Apixaban: 2.5 mg, BID
PLUS
Enoxaparin Placebo
干预措施: Apixaban (Drug)
A1
Apixaban: 2.5 mg, BID
PLUS
Enoxaparin Placebo
干预措施: Enoxaparin Placebo (Drug)
A2
Apixaban: 5 mg, BID
PLUS
Enoxaparin Placebo
干预措施: Apixaban (Drug)
A2
Apixaban: 5 mg, BID
PLUS
Enoxaparin Placebo
干预措施: Enoxaparin Placebo (Drug)
A3
Apixaban: 10 mg, BID
PLUS
Enoxaparin Placebo
干预措施: Apixaban (Drug)
A3
Apixaban: 10 mg, BID
PLUS
Enoxaparin Placebo
干预措施: Enoxaparin Placebo (Drug)
A4
Apixaban: 5 mg, QD
PLUS
Enoxaparin Placebo
干预措施: Apixaban (Drug)
A4
Apixaban: 5 mg, QD
PLUS
Enoxaparin Placebo
干预措施: Enoxaparin Placebo (Drug)
A5
Apixaban: 10 mg, QD
PLUS
Enoxaparin Placebo
干预措施: Apixaban (Drug)
A5
Apixaban: 10 mg, QD
PLUS
Enoxaparin Placebo
干预措施: Enoxaparin Placebo (Drug)
A6
Apixaban: 20 mg, QD
PLUS
Enoxaparin Placebo
干预措施: Apixaban (Drug)
A6
Apixaban: 20 mg, QD
PLUS
Enoxaparin Placebo
干预措施: Enoxaparin Placebo (Drug)
E1
Enoxaparin: 30 mg
PLUS
Apixaban Placebo
干预措施: Enoxaparin (Drug)
E1
Enoxaparin: 30 mg
PLUS
Apixaban Placebo
干预措施: Apixaban Placebo (Drug)
W1
Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0
干预措施: Warfarin (Drug)
结局指标
主要结局
Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery
时间窗: throughout the study
次要结局
- Assess the effect of QD and BID dose of BMS-562247 vs subcutaneous 30 mg q12h enoxaparin and warfarin on the composite endpoint of adjudication VTE events and all-cause death in subjects treated for 12 +/-2 days following surgery(throughout the study)
- Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with study medication for 12 +/-2 days following surgery(throughout the study)
- Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated minor bleeding events in subjects treated with study medication for 12 +/-2 days following surgery(throughout the study)
- To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule(throughout the study)