Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT05870605
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2023-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Use Study With Intuniv® in European Countries
Sponsor:
Shire
Organization:
Study Overview
Official Title:
Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) in European Countries
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: