Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study (20150338)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38953
• EU PAS number:
  EUPAS16049
• Study ID:
  38953
• Official title and acronym:
  Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study (20150338)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  This study was terminated prematurely and there were 0 exposed subjects and therefore no results to report.
• Study status:
  Ongoing

Research institution and networks

Institutions

Amgen

United States

Networks

Organization of Teratology Information Specialists (OTIS) Network

Study timelines

Date when funding contract was signed

Planned: 01/10/2016

Actual: 20/10/2016

Study start date

Planned: 22/12/2016

Actual: 22/12/2016

Data analysis start date

Planned: 08/06/2032

Actual: 22/07/2020

Date of final study report

Planned: 14/02/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

Protocol-Published Original evolocumab 20150338 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)