A post-marketing surveillance study for Repatha Inj. (evolocumab) in Korea text (20160156)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29447
• EU PAS number:
  EUPAS19680
• Study ID:
  29447
• Official title and acronym:
  A post-marketing surveillance study for Repatha Inj. (evolocumab) in Korea text (20160156)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To assess the safety and efficacy of Repatha in post-marketing routine clinical settings as required by the Ministry of Food and Drug Safety.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 30 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/11/2017

Actual: 01/11/2017

Study start date

Planned: 29/03/2019

Actual: 09/04/2019

Data analysis start date

Planned: 20/02/2023

Actual: 27/01/2023

Date of final study report

Planned: 12/07/2023

Actual: 07/08/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Repatha PMS_20160156_ver 1 redacted

Regulatory

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