RETrospective Observational Study of Evolocumab Use in Spanish Endocrinology Units (RETOSS-Endo) (20160140)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31421
• EU PAS number:
  EUPAS20043
• Study ID:
  31421
• Official title and acronym:
  RETrospective Observational Study of Evolocumab Use in Spanish Endocrinology Units (RETOSS-Endo) (20160140)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  RETrospective Observational Study of Evolocumab Use in Spanish Endocrinology Units to describe the main clinical characteristics (LDL-C levels, Diabetes status, FH status prior to treatment initiation) of patients with hyperlipidemia initiating evolocumab in Hospital Endocrinology Units.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 21 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/09/2017

Actual: 01/09/2017

Study start date

Planned: 15/09/2017

Actual: 14/09/2017

Data analysis start date

Planned: 30/04/2018

Actual: 17/09/2018

Date of final study report

Planned: 28/08/2019

Actual: 27/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20160140_01.02.06 Public Redacted Protocol Ver 1.0 2017-04-21 English

Regulatory

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