EUCTR2007-002630-11-DE进行中（未招募）不适用
A phase III randomised, parallel group, double-blind, active controlledstudy to investigate the efficacy and safety of oral 220 mg dabigatranetexilate (110 mg on the day of surgery followed by 220 mg once daily)compared to subcutaneous 40 mg enoxaparin once daily for 28-35 daysin prevention of venous thromboembolism in patients followingprimary elective total hip arthroplasty. (RE-NOVATE II) - RE-NOVATE II
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,920
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients scheduled to undergo primary, unilateral, elective total hip replacement.
- •Male or female 18 years of age or older.
- •Patients giving written informed consent for study participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of bleeding diathesis.
- •Excessive risk of bleeding in the investigator's judgement or anticipated need of quinidine, verapamil or other restricted medication during the treatment period.
- •Ongoing treatment for VTE.
- •Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding).
- •Liver disease expected to have any potential impact on survival.
- •Known severe renal insufficiency (CrCl <30 ml/min).
- •Pre-menopausal women who:
- •a.Are pregnant.
- •b.Are nursing.
- •c.Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study.
研究者
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