Status: Finalised
First registered on:
21/11/2014
Last updated on:
28/02/2019
1. Study identification
EU PAS Register NumberEUPAS7998
Official titleDrug Utilization Study for azilsartan medoxomil in Germany
Study title acronym
Study typeObservational study
Brief description of the studyA retrospective analyses of the IMS Disease Analyzer database to describe prescribing and morbidity patterns in patients prescribed azilsartan medoxomil in Germany.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
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 Ehlken
First name Birgit
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
National study
Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/03/201431/10/2014
Start date of data collection30/06/201401/11/2014
Start date of data analysis30/06/201401/11/2014
Date of interim report, if expected31/12/201401/10/2017
Date of final study report31/12/201829/10/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTDC Europe100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Dolin
First name Paul
Address line 161 Aldwych
Address line 2
Address line 3
CityLondon
PostcodeWc2B 4AE
CountryUnited Kingdom
Phone number (incl. country code)4402031168000
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Dolin
First name Paul
Address line 161 Aldwych
Address line 2
Address line 3
CityLondon
PostcodeWc2B 4AE
CountryUnited Kingdom
Phone number (incl. country code)4402031168000
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Single-Constituent (Substance INN)AZILSARTAN MEDOXOMIL
Product NameEdarbi
CountryGermany
Substance INN(s)AZILSARTAN MEDOXOMIL
7. Medical conditions to be studied
Medical condition(s)Yes
Essential hypertension
8. Population under study
Age
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 subjects1156
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
IMS Lifelink EMS database, Germany
Sources of data
Routine primary care electronic patient registry
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 primary study objective is to describe the population being prescribed azilsartan medoxomil in terms of demographics (age and gender) and ICD-10 CM based (co-) morbidities.
Are there primary outcomes?No
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
Descriptive analysis of prescribing patterns.
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
Submitted
Signed Code of Conduct Declaration
Submitted
Signed Checklist for Study
Protocols
Submitted
