NCT00839163已完成2 期
ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 613
- 主要终点
- Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with acute symptomatic proximal deep vein thrombosis
排除标准
- •Contraindication to comparator drugs
- •Symptomatic Pulmonary embolism
- •Conditions with increased bleeding risk
- •Unstable patients with reduced life expectancy
- •Severe renal impairment
- •Impaired liver function
- •Strong CYP 3A4 inhibitors
- •Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics
- •NSAIDs with half-life > 17 hours
研究组 & 干预措施
Arm 2
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
Arm 1
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
Arm 3
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
Arm 4
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
Arm 5
Active Comparator
干预措施: Enoxaparin/Vitamin K-Antagonist (Drug)
结局指标
主要结局
Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
时间窗: 21 days
次要结局
- Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan(Day 21)
- Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)(Day 84)
- Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)(Day 1-84)
- Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period(Day 1-84)
- Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug(Day 1-114)
研究者
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