Calendario›SNY›SanOrg34006
SanOrg34006
Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)
Ensayo de Sanofi en Deep Vein Thrombosis (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 1.452
- Centros
- 24
- Fin del objetivo primario
- sep 2005
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en may 2003.
Qué mide
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPatients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.
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Ficha completa en ClinicalTrials.gov (NCT00067093), actualizada en abr 2011.