Status: Finalised
First registered on:
23/01/2017
Last updated on:
11/03/2019
1. Study identification
EU PAS Register NumberEUPAS17371
Official titleStrattera patient exposures and adherence in the United Kingdom, Germany, the Netherlands, and Sweden: 2018 Bi-annual assessment report
Study title acronymB4Z-MC-B026
Study typeOther: Drug utilisation study
Brief description of the studyThe objective of this study is to describe atomoxetine (Strattera) utilization patterns for patients treated in the United Kingdom (UK), Germany, the Netherlands, and Sweden from the time period of 2012 through 2016.
Was this study requested by a regulator?Yes: United Kingdom
Is the study required by a Risk Management Plan (RMP)?
EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Details of (Primary) lead investigator
Title Dr
Last name Meyers
First name Kristin
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
International study
Germany
Netherlands
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed26/08/201326/08/2013
Start date of data collection01/04/201701/04/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report30/03/201812/03/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Meyers
First name Kristin
Address line 1Lilly Corporate Center
Address line 2
Address line 3
CityIndianapolis
Postcode46285
CountryUnited States
Phone number (incl. country code)13172777831
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Meyers
First name Kristin
Address line 1Lilly Corporate Center
Address line 2
Address line 3
CityIndianapolis
Postcode46285
CountryUnited States
Phone number (incl. country code)13172777831
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)N06BA09 (atomoxetine)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects37314
Additional information
The above estimated number represents the number of prevalent users in 2014 from the last iteration of this study (B4Z-MC-B025). The current study is an update and sample size is determined by usage as outlined in the Analysis Plan (usage between 2012 and 2016), not statistical power.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
Disease Analyzer, United Kingdom
Longitudinal Prescription Data, Germany
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Exposure registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
The main objective is to describe atomoxetine (Strattera) utilization patterns for patients treated in Germany, United Kingdom, Sweden, and the Netherlands.
Are there primary outcomes?Yes
Patient exposures, patient discontinuation and adherence, and descriptive statistics.
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
For each country, patient counts will be provided for the most recent 5 calendar years. Counts and proportions will be tabulated by country, year, age group, gender, and formulation (capsule/oral solution). Patient exposures, including treatment duration, daily average dose, and frequent comorbid diagnoses will be presented (where available). Measures of utilization will be described for new users within the most recent 24 month follow-up for capsule users and 18 month follow-up for oral solution users. This includes: 1) percentage of patient discontinuation, reinitiation, and adherence, 2) mean and median length of therapy, as well as daily dose, and 3) distribution of the percentage of patients having undergone one or more recent treatment episodes over the follow-up period. Descriptive statistics will include patient count/frequencies by age, gender and formulation. Common comorbidities and concomitant medications will be summarized.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
