EUCTR2005-005326-30-ES进行中（未招募）1 期
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3月6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
- 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
- •TVP sintomática aguda confirmada de las extremidades inferiores.
- •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
- •Limitaciones de edad mínima legal (pacientes menores de 18 años).
- •Aclaramiento de creatinina < 30 mL/min.
- •Enfermedad hepática severa.
- •Endocarditis bacteriana.
- •Hemorragia activa o riesgo elevado de hemorragia.
- •Hipertensión no controlada: presión arterial sistólica > 180 mmHg o presión arterial diastólica > 110 mmHg.
- •Embarazo o edad fértil sin medidas anticonceptivas adecuadas.
- •Periodo de lactancia.
- •Alergia conocida a idraparinux, SSR126517E, o a las proteínas del huevo.
- •Criterios relacionados con la metodología del estudio
- •Consentimiento informado por escrito no firmado.
- •Indicación de uso prolongado de anticoagulantes por otra razón que no sea TVP de extremidades inferiores.
- •Embolismo pulmonar sintomático (EP).
- •Cualquier administración o utilización intencionada de un agente fibrinolítico, trombectomía, inserción de un filtro caval, para tratar el episodio actual de TVP.
- •Más de 36 horas de tratamiento pre-aleatorización con dosis terapéuticas de Heparina (BPM), fondaparinux o inicio de tratamiento con AVK antes de la aleatorización.
- •Esperanza de vida < 6 meses.
- •Participación en otro estudio farmacoterapéutico durante los 30 días previos.
- •Imposibilidad de cumplir los requisitos del protocolo.
- •Criterios de exclusión al final del periodo de 6 meses de tratamiento para participar en la evaluación del efecto neutralizador de avidina.
- •Paciente que recibe avidina de forma abierta durante el estudio.
- •Paciente que precisa tratamiento anticoagulante durante más de 6 meses.
研究者
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