CHANT (Cerebral Hemorrhage And NXY Treatment) A double-blind, randomized, placebo-controlled, parallel-group, multicenter, phase IIb study to assess the safety and tolerability of 72 hours intravenous...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-000566-12

CHANT (Cerebral Hemorrhage And NXY Treatment) A double-blind, randomized, placebo-controlled, parallel-group, multicenter, phase IIb study to assess the safety and tolerability of 72 hours intravenous infusion of NXY 059 in adult patients with acute intracerebral hemorrhage (ICH)

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Extrait

The primary objective of this study is to assess the safety and tolerability of NXY-059 compared to placebo in patients with acute ICH by assessment of mortality (overall and by cause), the incidence of serious adverse events, the incidence of adverse events, change from baseline in the laboratory parameters, change from baseline in vital signs, incidence of abnormalities and change from baseline in ECG parameters, and change from baseline in neuroimaging scans.


Critère d'inclusion

  • Acute intracerebral hemorrhage not caused by trauma or tumor or being secondary to acute ischemic stroke, i.e hemorrhagic transformation

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