Observational Serial Chart Review of Repatha® Use in European Subjects with Hyperlipidaemia (20130296)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47822
• EU PAS number:
  EUPAS13328
• Study ID:
  47822
• Official title and acronym:
  Observational Serial Chart Review of Repatha® Use in European Subjects with Hyperlipidaemia (20130296)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Germany

  Greece

  Italy

  Poland

  Portugal

  Slovakia

  Spain

  Sweden

  Switzerland
• Study description:
  Review of clinical characteristics of patients who are prescribed Repatha and how their treatment is managed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 250 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 18/12/2015

Actual: 18/12/2015

Study start date

Planned: 29/04/2016

Actual: 04/05/2016

Data analysis start date

Planned: 26/07/2021

Actual: 13/09/2021

Date of final study report

Planned: 30/05/2022

Actual: 24/05/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc

Study protocol

Initial protocol

01.20.01 Protocol Ver 1.0 2015-11-19 English

Updated protocol

20130296_01.02.06 Public Redacted Protocol Ver 1.0 2018-12-20 English

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable