Status: Ongoing First registered on: 07/08/2023
Last updated on: 16/11/2023
1. Study identification
EU PAS Register NumberEUPAS106052
Official titleDARWIN EU® CC - Co-prescribing of endothelin receptor antagonists (ERAs) and phosphodiesterate-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH)
Study title acronym
Study typeObservational study
Brief description of the studyResearch question What is the utilization pattern of endothelin receptor antagonists (ERAs) and phosphodiesterase-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH)? Study objectives Objective 1: To estimate proportions of patients with newly diagnosed pulmonary arterial hypertension (PAH) who initiate treatment with endothelin receptor antagonists (ERAs) or phosphodiesterase-5 inhibitors (PDE-5is), either as monotherapy or in combination, during the period from January 1, 2012, to December 31, 2022. Objective 2: To estimate the duration of prescription for ERAs and PDE-5is in patients with newly diagnosed PAH between January 1, 2012, and December 31, 2022. Objective 3: To describe the prescription patterns and sequences of ERAs and PDE-5is in patients with newly diagnosed PAH between January 1, 2012, and December 31, 2022. Objective 4: To estimate the proportion of patients with newly diagnosed PAH who experience specific events of interest, namely: cardiovascular hospitalization, all-cause hospitalization, and death, after initiating treatment with ERAs and PDE-5isPAH between January 1, 2012, and December 31, 2022.
Was this study requested by a regulator?Yes: EMA
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 nameDARWIN EU® CC
Centre locationRotterdam, the Netherlands
Details of (Primary) lead investigator
Title Mr
Last name Arinze
First name Johnmary
Is this study being carried out with the collaboration of a research network?
Yes

DARWIN EU CC
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4
University of Oxford – CPRD data, United Kingdom
IQVIA DA Germany, Germany
CHUBX France, France
University of Tartu - Estonian Biobank, Estonia
Countries in which this study is being conducted
International study

Estonia
France
Germany
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/05/202304/05/2023
Start date of data collection01/01/201201/01/2012
Start date of data analysis
Date of interim report, if expected
Date of final study report30/11/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Arinze
First name Johnmary
Address line 1Dr. Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015GD 
CountryNetherlands
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org
Public Enquiries
Title Ms 
Last name Schuemie 
First name Ilse 
Address line 1Dr. Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015GD 
CountryNetherlands 
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address study@darwin-eu.org 
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