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) - CHANT

AstraZeneca AB0 个研究点目标入组 600 人开始时间: 2004年8月27日最近更新: 2012年3月19日

研究概览

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•Males and females =18 years of age.
•A clinical diagnosis of acute stroke with limb weakness as part of the presenting deficit(s) and a neuroimaging scan (CT or MRI) showing an ICH.
•Onset of symptoms within 6 hours of the planned start of investigational product infusion. Onset time for patients who awake with symptoms is defined as the last time the patient was awake without symptoms of stroke.
•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

•Evidence from neuroimaging (CT or MRI scan) or other pre?randomization investigations of another cause of the symptom than ICH
•Unconsciousness (ie, 3 on item 1a. on the NIHSS score).
•Severe concurrent illness with life expectancy less than 6 months.
•Known severe renal disorder from the patient's history. Patients with a known calculated creatinine clearance of <30 mL/min using the Jaffe method or <35mL/min using the modified Jaffe or enzymatic method to determine S-Creatinine should be excluded.
•Pregnancy or breast-feeding. Women must be either post-menopausal (judged by the investigator), permanently sterilized or, if of childbearing potential must have a negative test for pregnancy obtained before randomization and use appropriate contraception at least 3 weeks before randomization until 7 days after last dose of investigational product.

发起方