EUCTR2004-004803-39-BEActive, not recruitingNot Applicable
SAINT II (Stroke - Acute Ischemic - NXY Treatment)A double blind, randomized, placebo controlled, parallel group,multicenter, phase IIb/III study to assess the efficacy and safety ofintravenous NXY-059 in acute ischemic stroke - SAINT-II
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 3,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Provision of written informed consent.
- •Males and females =18 years of age.
- •A clinical diagnosis of acute ischemic stroke with limb weakness as part of the presenting deficit(s).
- •Onset of symptoms within 6 hours of the start of investigational product infusion. Onset time for subjects who awake with symptoms is defined as the last time the subject 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
Exclusion Criteria
- •Evidence from neuroimaging studying (CT or MRI scan) or other pre-randomization investigations of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke (onset within 6 hours) likely to cause the present symptoms.
- •Unnconsciousness
- •Severe concurrent illness with life expectancy less than 6 months.
- •Known severe renal disorder from the subject's history. Subjects with a known calculated creatinine clearance of <30 mL/min 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.
Investigators
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