CTRI/2010/091/000317已完成3 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.
Daiichi Sankyo Pharma Development0 个研究点目标入组 7,500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
入选标准
- •Ages Eligible for Study: 18 Years and older
- •Genders Eligible for Study: Both
- •Accepts Healthy Volunteers: No
- •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
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)More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
- •3)Calculated CrCL < 30 mL/min;
- •4)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) x 1.5 times the ULN;
- •5)patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
- •6)active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
- •7)chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
- •8)treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
- •9)concurrent treatment with potent P-gp inhibitors;
- •10)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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