Evaluation of the safety profile of lurasidone: a post-authorization safety study using United States administrative claims databases (Lurasidone PASS program)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40822
• EU PAS number:
  EUPAS34004
• Study ID:
  40822
• Official title and acronym:
  Evaluation of the safety profile of lurasidone: a post-authorization safety study using United States administrative claims databases (Lurasidone PASS program)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The aim of this PASS study is to evaluate the safety profile of lurasidone for treatment of schizophrenia in a real-world setting. The primary objective is to compare the incidence of important identified risks and important potential risks in patients treated with lurasidone to patients treated with other second generation oral atypical antipsychotics (OAAs).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Angelini Pharma

Study timelines

Date when funding contract was signed

Actual: 13/12/2019

Study start date

Actual: 05/03/2020

Date of final study report

Planned: 30/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Angelini Pharma SpA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)