Drug Use Study With Intuniv® in European Countries
Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) in European Countries
3 other identifiers
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFirst Submitted
Initial submission to the registry
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
May 23, 2023
CompletedAugust 22, 2023
August 1, 2023
3.5 years
May 12, 2023
August 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Number of Participants Categorised Based on Their Demographic Characteristics
The demographic characteristics will include age and gender.
Up to 4 years
Number of Participants with Co-morbidities
Up to 4 years
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
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
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 Outcomes (4)
Number of Physician Visits During the First Year of Therapy
Up to 4 years
Frequency of Weight Monitoring of Participants by Physician
Up to 4 years
Frequency of Blood Pressure Monitoring of Participants by Physician
Up to 4 years
Frequency of Heart Rate Monitoring of Participants by Physician
Up to 4 years
Study Arms (2)
Database Survey
All prescriptions for Intuniv available in the database in Denmark, Germany, Norway, Spain, Sweden, and the United Kingdom will be analyzed.
Physician Survey
The physicians will collect participant records of those who have been prescribed Intuniv® at least once during the study period of 4 years. This will be done in Belgium, Finland, Ireland, and the Netherlands.
Interventions
This is an observational study utilizing historical de-identified patient level data; therefore no intervention is given.
Eligibility Criteria
Prescribers of Intuniv® in the European countries.
You may qualify if:
- 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.
You may not qualify if:
- Physicians who do not treat participants or who may have a conflict of interest (i.e. physicians employed by regulatory bodies or pharmaceutical industries).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
Real World Insights EMEA IQVIA Commercial GmbH & Co. OHG
Munich, Bavaria, 80637, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Shire
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2023
First Posted
May 23, 2023
Study Start
November 15, 2018
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
August 22, 2023
Record last verified: 2023-08
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.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.