EUCTR2005-005326-30-IT进行中（未招募）不适用
International, multicenter, randomized, parallel group, double-blind study, in patients with acute symptomatic deep vein thrombosis of the lower limbs, demonstrating the bioequipotency at steady state of equimolar doses of SSR126517E 3.0 mg once a week and SR34006 2.5 mg once a week, documenting the safety and efficacy of both compounds during a 6-month treatment, and demonstrating the neutralizing effect of SSR29261 on the SSR126517E-induced anti-Xa activity - EQUINOX
Sanofi-Synthelabo Recherche0 个研究点目标入组 700 人开始时间: 2006年10月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
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
- •Confirmed acute symptomatic DVT of the lower limbs.
- •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-Exclusion criteria before initial randomization Legal lower age limitations country specific . Creatinine clearance 30 mL/min. Severe hepatic disease. Bacterial endocarditis. Active bleeding or high risk for bleeding. Uncontrolled hypertension systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg. Pregnancy or childbearing potential without proper contraceptive measures. Breastfeeding. Known allergy to idraparinux, SSR126517E, or egg proteins. -Criteria related to study methodology Written informed consent not signed. Indication of prolonged anticoagulation for other reason than DVT of the lower limbs. Symtomatic pulmonary embolism PE . Any administration or intended use of a fibrinolytic agent, thrombectomy, insertion of a caval filter, to treat the current episode of DVT. More than 36 hours pre-randomization treatment with therapeutic dosages of LMW Heparin, fondaparinux or initiation of VKA treatment prior to randomization Life expectancy 6 months. Participation in another pharmacotherapeutic study within the prior 30 days. Impossibility to meet protocol requirements. 2-Exclusion criteria at the end of the 6-month treatment period for participation in the avidin neutralizing effect assessment Patient receiving open-label avidin during the study. Patient requiring more than 6-month anticoagulant treatment
研究者
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