Site
Sydney, New South Wales, 2000, Australia
NCT Number: NCT04866030
This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia.
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Notify Me6 year–17 year
All sexes
Observational
Sydney, New South Wales, 2000, Australia
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: longitudinal participant level prescription database ii) Physician survey: de-identified participant data provided by representative physicians in Australia
In the NostraData database, actual prescription data are collected, which allows generation of information on drug usage. However, these prescription data do not contain patient variables such as age and indication needed to monitor potential off-label use. Therefore, these data must be supplemented with another data source. The physician survey will provide the data not included in the NostraData database.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 3 years
Number of Participants Based on Indication of Use of Intuniv will be assessed.
Time frame: Up to 3 years
Number of participants with presence/absence of contraindications will be assessed.
Time frame: Up to 3 years
Patterns of drug use will include daily dose, first time user, repeat user, treatment duration, treatment gaps, discontinuation of ADHD therapy and switch of therapy, co-prescriptions of ADHD medication.
Time frame: Up to 3 years
Participants will be stratified based on prescriber information which include specialty, graduation year, gender, location, and region.
Time frame: Up to 3 years
Frequency of weight monitoring of participants by physician will be reported.
Time frame: Up to 3 years
Frequency of blood pressure monitoring of participants by physician will be reported.
Time frame: Up to 3 years
Frequency of heart rate monitoring of participants by physician will be reported.
Shire
Industry
Drug Utilization Study With Intuniv® in Australia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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