NCT05870605

Drug Use Study With Intuniv® in European Countries

Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) in European Countries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate and characterize people who are taking Intuniv, analyze prescribing behaviors of physicians, and determine whether Intuniv was correctly prescribed in Belgium, Denmark, Finland, Germany, Ireland, Netherlands, Norway, Spain, Sweden, and the United Kingdom.

Detailed description

The study aims to characterize participants who are prescribed Intuniv® and describe prescribing patterns of Intuniv® among physicians in European countries. This study will collect data from the following sources: * Physician Survey: de-identified patient data provided by representative physicians in Belgium, Finland, Ireland, and the Netherlands, with a goal of data from up to 100 participants per survey wave. * Database Survey: longitudinal patient-level prescription database in all other countries with data on approximately 5000 participants. In the database study, actual prescription data are collected from electronic medical records and national registries. A prescriber survey will be conducted to evaluate health care professionals (HCPs) real-life practice. It will include data collection from the prescriber's (physician's) files and a web questionnaire, including de-identified data from up to 100 participants per survey wave.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
OTHER	No Intervention	This is an observational study utilizing historical de-identified patient level data; therefore no intervention is given.

Timeline

• Start date: 2018-11-15
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2023-05-23
• Last updated: 2023-08-22

Locations

1 site across 1 country: Germany