A multi-center, observational prospective post-authorization safety study to compare the cardiovascular risks and long-term safety of OZAWADE® in patients with obstructive sleep apnoea treated or not by primary therapy and exposed or not to OZAWADE® when used in routine medical practice

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  OZAWADE
• Anatomical Therapeutic Chemical (ATC) code:
  (N07XX11) pitolisant

  pitolisant
• Medical condition to be studied:
  Obstructive sleep apnoea syndrome

Study design details

• Main study objective:
  The primary objective of this study is to demonstrate that OZAWADE® supplementation in obstructive sleep ; apnoea (OSA) patients does not increase the incidence of cardiovascular events (CVE) compared with ; OZAWADE® unexposed patients (non-inferiority) and to evaluate the long-term safety of OZAWADE® when ; used as per SmPC in patients with OSA.