Drug Use Study With Intuniv® in European Countries

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05870605
• Other study ID #: SHP503-802
• Secondary ID: EUPAS18739EUPAS1
• Status: Completed
• Start date: November 15, 2018
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Prescribers of Intuniv®, i.e. physicians who know and have prescribed the drug at least once during the previous 12 months (or, for the first report, since country specific launch) (paediatricians, psychiatrists, neurologists and GPs).
• Participants who have been prescribed Intuniv® at least once during the reporting period.

Exclusion Criteria:

• Physicians who do not treat participants or who may have a conflict of interest (i.e. physicians employed by regulatory bodies or pharmaceutical industries).

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Other:
• No Intervention
This is an observational study utilizing historical de-identified patient level data; therefore no intervention is given.

Locations

Country	Name	City	State
Germany	Real World Insights EMEA IQVIA Commercial GmbH & Co. OHG	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Stratified by Prescriber Information Based on Physician Survey	Participants will be stratified based on prescriber information which include demographics, specialty, and setting of prescriber.	Up to 4 years
Primary	Number of Participants Categorised Based on Their Demographic Characteristics	The demographic characteristics will include age and gender.	Up to 4 years
Primary	Number of Participants with Co-morbidities		Up to 4 years
Primary	Number of Participants Based on Indication of Use of Prescribed Intuniv®	Indication of use (diagnosis) will be assessed as per World Health Organization (WHO) 10th International Statistical Classification of Diseases and Related Health Problems (ICD) classification.	Up to 4 years
Primary	Number of Participants With ADHD Categorised Based on Different Patterns of Intuniv® Use	Patterns of drug use include first time users, repeat users, participants who discontinued the ADHD therapy, participants with switches in treatment (both from Intuniv® to other ADHD medications and other ADHD medications to Intuniv®), and participants with dosing/overdose (defined as daily dose of >7 mg or of >4mg in participants =12 years of age).	Up to 4 years
Primary	Number of Participants Using Intuniv® as Second Line Treatment After Psychostimulant Prescription at any Time Prior to the Participant's First Prescription of Intuniv®		Up to 4 years
Secondary	Number of Physician Visits During the First Year of Therapy		Up to 4 years
Secondary	Frequency of Weight Monitoring of Participants by Physician	Frequency of weight monitoring of participants by physician will be reported.	Up to 4 years
Secondary	Frequency of Blood Pressure Monitoring of Participants by Physician	Frequency of blood pressure monitoring of participants by physician will be reported.	Up to 4 years
Secondary	Frequency of Heart Rate Monitoring of Participants by Physician	Frequency of heart rate monitoring of participants by physician will be reported.	Up to 4 years

External Links

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