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clopidogrel

Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

Ensayo de Sanofi en Peripheral Arterial Disease (PAD) (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

431

previstos

Centros

1

Fin del objetivo primario

may 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2009.

Qué mide

Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...) (Week 12 (on treatment)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary objective: * To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD) Secondary objectives: * To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine * To compare the risk of vascular events of clopidogrel with ticlopidine * To document the long-term safety of clopidogrel for a total of 52 weeks * To document the vascular events of clopidogrel for a total of 52 weeks

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00862420), actualizada en jul 2012.