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

Phase 1

• Conditions: Acute ischemic stroke.

• Registration Number: EUCTR2004-004803-39-ES
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-04
• Study Completion: 2006-09-19
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3200

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified