Disease characteristics and outcomes of pulmonary arterial hypertension in children and adolescents in real-world clinical settings: Sytematic Review of prospective, observational registries (Pediatric Systematic Review)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25541
• EU PAS number:
  EUPAS4523
• Study ID:
  25541
• Official title and acronym:
  Disease characteristics and outcomes of pulmonary arterial hypertension in children and adolescents in real-world clinical settings: Sytematic Review of prospective, observational registries (Pediatric Systematic Review)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Brazil

  Canada

  China

  Denmark

  France

  Germany

  Greece

  Hungary

  Italy

  Japan

  Mexico

  Netherlands

  Norway

  Poland

  Switzerland

  Türkiye

  United Kingdom

  United States
• Study description:
  Systematic review of aggregated results from the prospective, observational disease registries : TOPP, French registry of PAH in children, Netherlands national registry, REVEAL (Registry to Evaluate Early And Long-Term PAH Disease Management, United States)
• Study status:
  Finalised

Research institutions and networks

Institutions

Actelion Pharmaceuticals

Actelion Pharmaceuticals

Networks

TOPP Registry, FR Pediatric Registry, NL National Registry, REVEAL

Study timelines

Date when funding contract was signed

Actual: 01/07/2009

Study start date

Actual: 01/07/2009

Date of final study report

Actual: 18/07/2018

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)