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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS40684 | Registry Identifier | EU PAS Registry |
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This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Based on Indication of Use of Intuniv | Number of Participants Based on Indication of Use of Intuniv will be assessed. | Up to 3 years |
| Number of Participants with Presence/Absence of Contraindications | Number of participants with presence/absence of contraindications will be assessed. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Based on Patterns of Drug Use | 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. | Up to 3 years |
| Number of Participants Stratified by Prescriber Information Based on Physician Survey |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who have been prescribed Intuniv at least once during the reporting period.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site | Sydney | New South Wales | 2000 | Australia |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
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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.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Participants will be stratified based on prescriber information which include specialty, graduation year, gender, location, and region. |
| Up to 3 years |
| Frequency of Weight Monitoring of Participants by Physician | Frequency of weight monitoring of participants by physician will be reported. | Up to 3 years |
| Frequency of Blood Pressure Monitoring of Participants by Physician | Frequency of blood pressure monitoring of participants by physician will be reported. | Up to 3 years |
| Frequency of Heart Rate Monitoring of Participants by Physician | Frequency of heart rate monitoring of participants by physician will be reported. | Up to 3 years |