EUCTR2009-014290-40-FR进行中（未招募）1 期
A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism - Evaluation of edoxaban vs. warfarin in subjects with symptomatic venous thromboembolism (VTE)
Daiichi Sankyo Development Limited0 个研究点目标入组 7,500 人开始时间: 2009年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7,500
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. Male or female subjects older than the minimum legal adult age (country specific)
- •2. Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging
- •3. Able to provide 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. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
- •2. Indication for warfarin other than DVT and/or PE
- •3. More than 48 hours pre-treatment with therapeutic dosages of anticoagulant treatment (LMWH, UFH, and fondapiranux per local labeling) or more than a single dose of a VKA prior to randomization to treat the current episode
- •4. Treatment with any investigational drug within 30 days prior to randomization
- •5. Calculated CrCL < 30 mL/min
- •6. Significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) = 2 times the upper limit of normal (ULN), or total bilirubin (TBL) ³ 1.5 times the ULN
- •7. Patients with active cancer for whom long term treatment with LMW(heparin) is anticipated
- •8. Life expectancy < 3 months
- •9. Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin
- •10. Uncontrolled hypertension as judged by the investigator (e.g., systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg despite antihypertensives)
- •11. Women of childbearing potential without proper contraceptive measures, and women who are pregnant or breast feeding
- •Note: Childbearing potential without proper contraceptive measures (i.e., 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 for the male partner)
- •12. Any other contraindication listed in the local labeling of LMWH, UFH, or warfarin
- •13. Chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) including both cyclooxygenase-1 (COX-1) and cyclooxygenase-2
- •(COX-2) inhibitors for ³ 4 days/week anticipated to continue during the study
- •14. Treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy (any two antiplatelet agents including aspirin plus any other oral or invravenous (IV) antiplatelet drug) anticipated to continue during the study
- •15. Treatment with the potent P-gp inhibitors ritonavir, nelfinavir, indinavir, or saquinavir anticipated to continue during the study
- •16. Systemic use of the strong P-gp inhibitors erythromycin, azithromycin, clarithromycin, ketoconazole or itraconazole at the time of randomization; subsequent use is permitted
- •17. Known history of positive Hepatitis B antigen or Hepatitis C antibody
- •18. Subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
研究者
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