EXPERT, EXPosurE Registry RiociguaT in patients with pulmonary hypertension

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43970
• EU PAS number:
  EUPAS6115
• Study ID:
  43970
• Official title and acronym:
  EXPERT, EXPosurE Registry RiociguaT in patients with pulmonary hypertension
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Austria

  Belgium

  Canada

  Colombia

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Ireland

  Italy

  Luxembourg

  Netherlands

  Norway

  Portugal

  Russian Federation

  Saudi Arabia

  Slovakia

  Spain

  Sweden

  Switzerland

  Taiwan

  Türkiye

  United Kingdom
• Study description:
  In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 28 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 20/11/2014

Actual: 28/01/2014

Study start date

Planned: 30/05/2014

Actual: 31/05/2014

Date of final study report

Planned: 30/04/2019

Actual: 28/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

EXPERT_16657_CSP_sign

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)