Status: Ongoing First registered on: 16/10/2017
Last updated on: 08/04/2019
1. Study identification
EU PAS Register NumberEUPAS21314
Official titleA drug utilization study (DUS) of alirocumab in Europe to assess the effectiveness of the dosing recommendation to avoid very low LDL-C levels
Study title acronymDUS
Study typeObservational study
Brief description of the studyThis is a drug utilization study to evaluate the effectiveness of the alirocumab dosing recommendations for the 3 approved dosage regimens to date, ie, 75 mg every two weeks, 150 mg every two weeks, and 300 mg once every 4 weeks (monthly) to avoid very low LDL C levels. The secondary objective is to describe the pattern of alirocumab utilization in real-world clinical practice with respect to the dosing recommendations in the labelling of the 3 approved dosage regimens to date, ie, 75 mg every two weeks, 150 mg every two weeks, and 300 mg once every 4 weeks (monthly) to avoid very low LDL-C levels.
Was this study requested by a regulator?Yes: EMA
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 applicableOBS14697
2. Research centres and Investigator details
Coordinating study entity
Centre nameSanofi
Centre locationChilly Mazarin
Details of (Primary) lead investigator
Title Dr
Last name Trial Transparency Team
First name Trial Transparency Team
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?1

IQVIA
Countries in which this study is being conducted
International study

Belgium
Germany
Italy
Netherlands
Norway
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/11/201706/11/2017
Start date of data collection30/03/201803/08/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSanofi/Regeneron100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Trial Transparency Team
First name Trial Transparency Team
Address line 11 Avenue Pierre Brossolette
Address line 2 
Address line 3 
CityChilly Mazarin 
Postcode08807 
CountryFrance
Phone number (incl. country code)33160497777 
Alternative phone number 
Fax number (incl. country code) 
Email address Contact-Us@sanofi.com
Public Enquiries
Title Dr 
Last name Trial Transparency Team 
First name Trial Transparency Team 
Address line 11 Avenue Pierre Brossolette 
Address line 2 
Address line 3 
CityChilly Mazarin 
Postcode08807 
CountryFrance 
Phone number (incl. country code)33160497777 
Alternative phone number 
Fax number (incl. country code) 
Email address Contact-Us@sanofi.com 
Top