Strattera patient exposures and adherence in the United Kingdom, Germany, the Netherlands, and Sweden: 2016 Bi-annual assessment report. (B4Z-MC-B025)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14862
• EU PAS number:
  EUPAS10786
• Study ID:
  14862
• Official title and acronym:
  Strattera patient exposures and adherence in the United Kingdom, Germany, the Netherlands, and Sweden: 2016 Bi-annual assessment report. (B4Z-MC-B025)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Netherlands

  Sweden

  United Kingdom
• Study description:
  The objective of this study is to describe atomoxetine utilisation patterns for patients treated in the United Kingdom, Germany, the Netherlands, and Sweden from the time period of 2008 through 2014. This will be done by:-Estimating number of patients exposed, stratified by age-Estimating duration of exposure, medication possession ratio, and dose over the most recent 24 months-Estimating number of patients restarting, gap between, and duration of additional exposures over most recent 24 months, for those who stopped taking Strattera-Describing common comorbidity and concomitant medications
• Study status:
  Finalised

Research institutions and networks

Institutions

IMS Health

Study timelines

Date when funding contract was signed

Planned: 26/08/2013

Actual: 26/08/2013

Study start date

Planned: 01/10/2015

Actual: 01/10/2015

Data analysis start date

Planned: 01/02/2016

Date of final study report

Planned: 31/03/2016

Actual: 21/03/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B025 PASS

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)