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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00061022




Registration number
NCT00061022
Ethics application status
Date submitted
20/05/2003
Date registered
21/05/2003
Date last updated
15/11/2010

Titles & IDs
Public title
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Scientific title
SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
Secondary ID [1] 0 0
007
Secondary ID [2] 0 0
SA-NXY-0007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Stroke 0 0
Stroke, Acute 0 0
Cerebrovascular Stroke 0 0
Ischemic Attack, Transient 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Global disability on modified Rankin scale at 90 days.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
NIH stroke scale
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Barthel Index
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Stroke Impact Scale
Timepoint [3] 0 0
Secondary outcome [4] 0 0
EQ-5D all at 90 days
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Safety outcomes
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
* Males and females
* Acute ischemic stroke with limb weakness
* Onset of symptoms within 6 hours
* Full functional independence prior to the present stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unconsciousness
* Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
* Severe illness with life expectancy less than 6 months.
* Known severe kidney disorder.
* Current known alcohol or illicit drug abuse or dependence.
* Pregnant or breast-feeding.
* Treatment with acetazolamide and methotrexate is not permitted during the infusion
* Participation in a previous clinical study within 30 days.
* Meets all other exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Box Hill
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Gosford
Recruitment hospital [5] 0 0
Research Site - Heidelberg
Recruitment hospital [6] 0 0
Research Site - New Lambton
Recruitment hospital [7] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Gosford
Recruitment postcode(s) [5] 0 0
- Heidelberg
Recruitment postcode(s) [6] 0 0
- New Lambton
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- Parkville
Recruitment outside Australia
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Newcastle-upon-Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca NXY-059 Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00061022