Status:
COMPLETED
Drug Use Study With Intuniv® in Australia
Lead Sponsor:
Shire
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
6-17 years
Brief Summary
This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia.
Detailed Description
This is a drug utilization study using retrospective database analysis where study will combine data from two sources of patient-level drug utilization data for Intuniv: i) NostraData database: longi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 27 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04866030
Start Date
March 11 2019
End Date
August 27 2021
Last Update
October 4 2021
Active Locations (1)
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1
Site
Sydney, New South Wales, Australia, 2000