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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04866030




Registration number
NCT04866030
Ethics application status
Date submitted
28/04/2021
Date registered
29/04/2021

Titles & IDs
Public title
Drug Use Study With Intuniv® in Australia
Scientific title
Drug Utilization Study With Intuniv® in Australia
Secondary ID [1] 0 0
EUPAS40684
Secondary ID [2] 0 0
SHP503-803
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
NostraData Database - All prescriptions for Intuniv available in the NostraData database in Austrialia will be analyzed in this study.

Physician Survey - Physician will collect medical record data of 100 participants who have been prescribed Intuniv at least once during the study period to treat participants with ADHD.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Based on Indication of Use of Intuniv
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Number of Participants with Presence/Absence of Contraindications
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Number of Participants Based on Patterns of Drug Use
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Number of Participants Stratified by Prescriber Information Based on Physician Survey
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Frequency of Weight Monitoring of Participants by Physician
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Frequency of Blood Pressure Monitoring of Participants by Physician
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Frequency of Heart Rate Monitoring of Participants by Physician
Timepoint [5] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
* Is indicated for the treatment of ADHD in children and adolescents 6 to 17 years old, as monotherapy.
* Must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use for participants with a diagnosis other than ADHD.
* Use for children less than 6 years of age.
* Use in adults (greater than or equal to [>=] 18 years of age)
* Prescribed overdose greater than (>) 7 milligram per day (mg/day) for participants > 12 years, or > 4 mg/ day for children lesser than or equal to (<=) 12 years.
* If monotherapy with Intuniv, no prior treatment with stimulants or atomoxetine.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/08/2021
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Site - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Shire
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


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/NCT04866030