Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000793516
Ethics application status
Approved
Date submitted
27/06/2024
Date registered
27/06/2024
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2024
Date results information initially provided
27/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
test trial 27/06/2024
Scientific title
test trial 27/06/2024
Secondary ID [1] 312414 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 334227 0
Condition category
Condition code
Cardiovascular 330895 330895 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
Intervention code [1] 328917 0
Treatment: Other
Comparator / control treatment
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
Control group
Active

Outcomes
Primary outcome [1] 338651 0
test trial 27/06/2024
Timepoint [1] 338651 0
test trial 27/06/2024
Secondary outcome [1] 436843 0
test trial 27/06/2024
Timepoint [1] 436843 0
test trial 27/06/2024

Eligibility
Key inclusion criteria
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024

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)
test trial 27/06/2024
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
test trial 27/06/2024
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316825 0
Government body
Name [1] 316825 0
test trial 27/06/2024
Country [1] 316825 0
Australia
Primary sponsor type
University
Name
test trial 27/06/2024
Address
Country
Australia
Secondary sponsor category [1] 319055 0
None
Name [1] 319055 0
Address [1] 319055 0
Country [1] 319055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315595 0
Australian Institute of Criminology Ethics Committee
Ethics committee address [1] 315595 0
https://www.aic.gov.au/about-us/governance/human-research-ethics-committee
Ethics committee country [1] 315595 0
Australia
Date submitted for ethics approval [1] 315595 0
Approval date [1] 315595 0
03/06/2024
Ethics approval number [1] 315595 0

Summary
Brief summary
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
test trial 27/06/2024
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135186 0
Dr test trial 27/06/2024
Address 135186 0
test trial 27/06/2024 test trial 27/06/2024
Country 135186 0
Australia
Phone 135186 0
+61 2 9562 5333
Fax 135186 0
Email 135186 0
[email protected]
Contact person for public queries
Name 135187 0
test trial 27/06/2024
Address 135187 0
test trial 27/06/2024 test trial 27/06/2024
Country 135187 0
Australia
Phone 135187 0
+61 2 9562 5333
Fax 135187 0
Email 135187 0
[email protected]
Contact person for scientific queries
Name 135188 0
test trial 27/06/2024
Address 135188 0
test trial 27/06/2024 test trial 27/06/2024
Country 135188 0
Australia
Phone 135188 0
+61 2 9562 5333
Fax 135188 0
Email 135188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
test trial 27/06/2024
When will data be available (start and end dates)?
test trial 27/06/2024
Available to whom?
test trial 27/06/2024
Available for what types of analyses?
test trial 27/06/2024
How or where can data be obtained?
test trial 27/06/2024


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23925Analytic code    test trial 27/06/2024
23926Clinical study report    test trial 27/06/2024
23927Data dictionary    test trial 27/06/2024
23928Ethical approval    test trial 27/06/2024
23929Informed consent form    test trial 27/06/2024
23930Statistical analysis plan    test trial 27/06/2024
23931Study protocol    test trial 27/06/2024
23932Other    test trial 27/06/2024


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23925Analytic code  [email protected] test trial 27/06/2024 update
23926Clinical study report    test trial 27/06/2024
23927Data dictionary    test trial 27/06/2024
23928Ethical approval    test trial 27/06/2024 update
23929Informed consent form    test trial 27/06/2024
23930Statistical analysis plan    test trial 27/06/2024
23931Study protocol    test trial 27/06/2024
23932Other    test trial 27/06/2024
23943Ethical approval    update

Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
AppendicesNo test trial 27/06/2024
Basic resultsNo test trial 27/06/2024
BookNo test trial 27/06/2024
Conference abstractNo test trial 27/06/2024
Conference posterNo test trial 27/06/2024
Funder reportNo test trial 27/06/2024
Interim results articleNo test trial 27/06/2024
Plain language summaryNo test trial 27/06/2024
ProtocolNo test trial 27/06/2024
Statistical analysis planNo test trial 27/06/2024
Study results articleNo test trial 27/06/2024
Supplementary materialsNo test trial 27/06/2024
ThesisNo test trial 27/06/2024
Other filesNo test trial 27/06/2024

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4885AppendicesNo test trial 27/06/2024
4886Basic resultsNo test trial 27/06/2024
4887BookNo test trial 27/06/2024 update
4888Conference abstractNo test trial 27/06/2024
4889Conference posterNo test trial 27/06/2024
4890Funder reportNo test trial 27/06/2024
4891Interim results articleNo test trial 27/06/2024
4892Plain language summaryNo test trial 27/06/2024
4893ProtocolNo test trial 27/06/2024
4894Statistical analysis planNo test trial 27/06/2024
4895Study results articleNo test trial 27/06/2024
4896Supplementary materialsNo test trial 27/06/2024
4897ThesisNo test trial 27/06/2024
4898Other filesNo test trial 27/06/2024
4899Funder reportYes update

Documents added automatically
No additional documents have been identified.