Status: Ongoing First registered on: 27/09/2018
Last updated on: 08/06/2020
1. Study identification
EU PAS Register NumberEUPAS25699
Official titlePost-authorisation safety study (PASS) to evaluate risk minimisation measures for medication errors with Uptravi during the titration phase in patients with pulmonary arterial hypertension (PAH) in clinical practice
Study title acronymEDUCATE
Study typeObservational study
Brief description of the studyThe study is an observational, cross-sectional survey of awareness, knowledge, and self-reported behaviour among a sample of health care professionals (HCPs) and two groups of patients. - Group A: a sample of patients administered the questionnaire at the time of initiating Uptravi - Group B: a separate sample of patients administered the questionnaire at completion of titration or discontinuation of Uptravi during titration This survey will be administered as a web-based questionnaire (HCPs and patients) with an option for patients to have a telephone interview or as a third option, for those who cannot use the web-based questionnaire or telephone interview, a paper version of the questionnaire can be sent and returned via post.
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 applicableAC-065A403
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Anthony
First name Mary
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?7
Countries in which this study is being conducted
International study

Germany
Netherlands
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/04/2018
Start date of data collection01/12/202001/12/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesActelion Pharmaceuticals Ltd100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Frentzel
First name Adrian
Address line 1Gewerbestrasse 16
Address line 2 
Address line 3 
CityAllschwil 
Postcode4123 
CountrySwitzerland
Phone number (incl. country code)41615656565 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-disclosure@its.jnj.com
Public Enquiries
Title Dr 
Last name Frentzel 
First name Adrian 
Address line 1Gewerbestrasse 16 
Address line 2 
Address line 3 
CityAllschwil 
Postcode4123 
CountrySwitzerland 
Phone number (incl. country code)41615656565 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-disclosure@its.jnj.com 
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