Drug Use Study With Intuniv® in Australia

NCT04866030 | Completed

• 2 other identifiers: SHP503-803EUPAS40684
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Number of Participants Based on Patterns of Drug Use

  Up to 3 years

• Number of Participants Stratified by Prescriber Information Based on Physician Survey

  Up to 3 years

• Frequency of Weight Monitoring of Participants by Physician

  Up to 3 years

• Frequency of Blood Pressure Monitoring of Participants by Physician

  Up to 3 years

• Frequency of Heart Rate Monitoring of Participants by Physician

  Up to 3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have been prescribed Intuniv at least once during the reporting period.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Site

Sydney, New South Wales, 2000, Australia

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Study Director

  Shire

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 29, 2021
• Study Start: March 11, 2019
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: 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.

Locations

AU (1)