Characterizing Repatha use among adult pregnant women, adult women of childbearing age and within the adult general population (NA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40717
• EU PAS number:
  EUPAS30072
• Study ID:
  40717
• Official title and acronym:
  Characterizing Repatha use among adult pregnant women, adult women of childbearing age and within the adult general population (NA)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Norway

  Sweden

  United Kingdom

  United States
• Study description:
  To describe the use of Repatha among adult (≥16 years of age) pregnant women, adult women of childbearing age (16-54 years) and within the adult general population.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 01/01/2019

Actual: 01/01/2019

Study start date

Planned: 15/07/2019

Actual: 15/07/2019

Data analysis start date

Planned: 01/05/2020

Actual: 01/05/2020

Date of final study report

Planned: 30/03/2021

Actual: 08/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20190050_01.02.06 Public Redacted Protocol Ver 1.0 2019-05-09 English

Updated protocol

20190050-protocol_public-redacted-approved-version_August 2019

Regulatory

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