EUCTR2005-005326-30-BE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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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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