Post-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 (EDUCATE)

Study identification

• EU PAS number:
  EUPAS25699
• Study ID:
  47541
• Official title and acronym:
  Post-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 (EDUCATE)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Greece

  Italy

  Poland

  Spain

  United Kingdom
• Study description:
  The study is an observational, cross-sectional survey of awareness, knowledge, and self-reported behaviour among a sample of health care professionals (HCPs) and patients at completion of titration or discontinuation of Uptravi during titration. This survey will be administered as a web-based questionnaire (HCPs and patients)
• Study status:
  Ongoing

Research institutions and networks

Institutions

Parexel International

United States

Study timelines

Date when funding contract was signed

Planned:30/04/2018

Study start date

Planned:01/12/2020

Actual:01/12/2018

Date of final study report

Planned:31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Actelion Pharmaceuticals Ltd

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)