A Post-marketing Database Surveillance to Investigate the Risk of Rhabdomyolysis and Myopathy in Hypercholesterolemic Patients Treated with ATOZET or Ezetimibe Atorvastatin coadministration in Japan (MK-0653C-854)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46429
• EU PAS number:
  EUPAS41341
• Study ID:
  46429
• Official title and acronym:
  A Post-marketing Database Surveillance to Investigate the Risk of Rhabdomyolysis and Myopathy in Hypercholesterolemic Patients Treated with ATOZET or Ezetimibe Atorvastatin coadministration in Japan (MK-0653C-854)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The purpose of this study is to investigate muscle health outcomes of interest (HOI) rhabdomyolysis and myopathy in participants who receive ATOZET compared to participants taking the 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 & Co.

Study timelines

Date when funding contract was signed

Actual: 21/08/2020

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.

Study protocol

Initial protocol

MK-0653C-854-00-v2-Final Redaction

Regulatory

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