A Post-marketing Database Surveillance to Investigate the Risk of Hepatic Events in Hypercholesterolemic Patients Treated with ATOZET or Ezetimibe Atorvastatin coadministration in Japan (MK-0653C-853)

Study identification

• EU PAS number:
  EUPAS41295
• Study ID:
  46425
• Official title and acronym:
  A Post-marketing Database Surveillance to Investigate the Risk of Hepatic Events in Hypercholesterolemic Patients Treated with ATOZET or Ezetimibe Atorvastatin coadministration in Japan (MK-0653C-853)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The purpose of the study is to investigate hepatic health outcomes of interest (HOI) fulminant hepatitis, hepatitis, jaundice in participants who receive ATOZET compared to participants with coadministration of ezetimibe and atorvastatin. It will also study these risks in participants with hepatic impairment.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

Study timelines

Date when funding contract was signed

Actual: 01/05/2020

Study start date

Planned: 12/06/2021

Actual: 11/06/2021

Data analysis start date

Planned: 01/09/2021

Actual: 08/09/2021

Date of final study report

Planned: 31/12/2021

Actual: 21/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only