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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000147
• EU PAS number:
  EUPAS1000000147
• Study ID:
  1000000147
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned: 16/09/2024

Actual: 23/09/2024

Study start date

Planned: 30/09/2024

Date of final study report

Planned: 15/12/2031

Study protocol

Initial protocol

OZAWADE_PASS_protocol_V3 0_23NOV2023_redacted.pdf

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)