EXPERT, EXPosurE Registry RiociguaT in patients with pulmonary hypertension

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ADEMPAS
• Medical condition to be studied:
  Pulmonary hypertension

Population studied

• Short description of the study population:
  Patients who have been prescribed Adempas® for a medically appropriate use will be eligible to be included into this registry. Indications and contraindications according to the local market authorization should carefully be considered.; Inclusion criterion/criteria; • Female and male patients who start or are on treatment with Adempas®; • Written informed consent; Exclusion criterion/criteria; • Patients currently participating in an interventional clinical trial
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with pulmonary hypertension
• Estimated number of subjects:
  900

Study design details

• Main study objective:
  The primary objective is the assessment of long-term safety of adempas in real life clinical practice
• Outcomes:
  1.Number of adverse events/ serious adverse events 2.all-cause mortality, 1.Number of adverse event (AE) and serious adverse event(SAE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH) )2. 6 minute walking distance3.Number of hospitalization/outpatient visitsMore details are posted on www.clinicaltrials.gov under NCT02092818.
• Data analysis plan:
  All background variables and outcome parameters will be analyzed descriptively.All analyses will be performed for the total study population and separately for PH subtype

Documents

Study results

16657_EU-PAS_Abstract_2019-06-03

16657_EU-PAS_Abstract_2019-09-06

Study report

16657_EXPERT CSR Addendum_Bayer_16MAR2020_Redacted

16657_EXPERT CSR_Final Report_Bayer_26 JUL 2019_Redacted

16657_EXPERT CSR_Final Report_Bayer_28MAY2019_Redacted

Study, other information

16657_EXPERT CSR_Final Report_Bayer_26 JUL 2019_Redacted.pdf

16657_EXPERT CSR_Final Report_Bayer_28MAY2019_Redacted.pdf