EUCTR2007-002586-12-BE进行中（未招募）1 期
Twice-daily oral direct thrombin inhibitor dabigatran in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. - Re-Sonate
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 1,800 人开始时间: 2008年4月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,800
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
- •1. Patients with confirmed symptomatic PE or proximal DVT who have been treated
- •for 6 to 18 months with an oral VKA (e.g., warfarin, acenocoumarol,
- •phenprocoumon, or fluindione)
- •2. Written informed consent
- •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
- •1. Younger then 18 years of age
- •2. Indication for VKA other than DVT and/or PE
- •3. Patients in whom anticoagulant treatment for their index PE or DVT should be
- •4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis,
- •chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
- •5. Creatinine clearance < 30 ml/min
- •6. Acute bacterial endocarditis
- •7. Active bleeding or high risk for bleeding.
- •8. Uncontrolled hypertension (investigators judgement)
- •9. Intake of another experimental drug within the 30 days prior to randomization
- •into the study
- •10. Life expectancy < 6months
- •11. Childbearing potential without proper contraceptive measures*, pregnancy or
- •breast feeding
- •*proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
- •12. Patients with known hypersensivity to dabigatran or any other component of the
- •investigational product
- •13. Patients deemed unsuitable for inclusion by the investigator, because
- •considered unreliable to comply with the requirements of the study and/or
- •compliance with study drug administration, or because having any condition or
- •disease which in the opinion of the investigator would not allow safe
- •participation in the study
研究者
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