Clinical trial NCT05870605: Drug Use Study With Intuniv® in European Countries
Official title: Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) in European Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prescribers of Intuniv® in the European countries.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants Stratified by Prescriber Information Based on Physician Survey
timeFrame: Up to 4 years
measure: Number of Participants Categorised Based on Their Demographic Characteristics
timeFrame: Up to 4 years
measure: Number of Participants with Co-morbidities
timeFrame: Up to 4 years
measure: Number of Participants Based on Indication of Use of Prescribed Intuniv®
timeFrame: Up to 4 years
measure: Number of Participants With ADHD Categorised Based on Different Patterns of Intuniv® Use
timeFrame: Up to 4 years
measure: Number of Participants Using Intuniv® as Second Line Treatment After Psychostimulant Prescription at any Time Prior to the Participant's First Prescription of Intuniv®
timeFrame: Up to 4 years
Secondary outcomes:
measure: Number of Physician Visits During the First Year of Therapy
timeFrame: Up to 4 years
measure: Frequency of Weight Monitoring of Participants by Physician
timeFrame: Up to 4 years
measure: Frequency of Blood Pressure Monitoring of Participants by Physician
timeFrame: Up to 4 years
measure: Frequency of Heart Rate Monitoring of Participants by Physician
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Real World Insights EMEA IQVIA Commercial GmbH & Co. OHG
state: Bavaria
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: