Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000174684
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
19/08/2005
Date last updated
19/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Anti-inflammatory effects of pioglitazone in acute stroke - a double-blind placebo controlled trial
Scientific title
Anti-inflammatory effects of pioglitazone in acute stroke - a double-blind placebo controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute stroke 269 0
Condition category
Condition code
Stroke 304 304 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pioglitazone 45mg/d given within 6 hours of ischaemic stroke and continued for 7 days.
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 357 0
Effect on various inflammatory markers
Timepoint [1] 357 0
At days 1, 3, 5, 7 and 14 after stroke.
Secondary outcome [1] 805 0
Stroke size and disability
Timepoint [1] 805 0
At 14 days.

Eligibility
Key inclusion criteria
Diabetes, acute ischaemic stroke.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contra-indication to pioglitazone, unable to obtain consent, pregnant, severe inflammatory illness.

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)
Numbered containers made up by hospital pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be via ClinStat (v3.2) software and will be stratified by patient sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 360 0
Other
Name [1] 360 0
Country [1] 360 0
Primary sponsor type
Individual
Name
Dr R W Simpson
Address
Country
Secondary sponsor category [1] 286 0
None
Name [1] 286 0
nil
Address [1] 286 0
Country [1] 286 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35668 0
Address 35668 0
Country 35668 0
Phone 35668 0
Fax 35668 0
Email 35668 0
Contact person for public queries
Name 9384 0
richard simpson
Address 9384 0
Box Hill Hospital
Nelson Road
Box Hill VIC 3128
Country 9384 0
Australia
Phone 9384 0
+61 3 98953333
Fax 9384 0
Email 9384 0
richard.simpson@med.monash.edu.au
Contact person for scientific queries
Name 312 0
Richard Simpson
Address 312 0
Box Hill Hospital
Nelson Road
Box Hill VIC 3128
Country 312 0
Australia
Phone 312 0
+61 3 98953333
Fax 312 0
Email 312 0
richard.simpson@med.monash.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.