Open-label study of long-term evaluation of AMG145 against LDL

• Research type

  Research Study

• Full title

  A Multicenter Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

• IRAS ID

  122937

• Contact name

  Michael Fisher

• Contact email

  michael.fisher@rlbuht.nhs.uk

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2012-004357-83

• Research summary

  The study is an open label extension study to 3 other approved studies taking place within the UK. Patients who complete these ’parent’ studies will be eligible to take part in this study.
  The study will assess the safety and tolerability of the long term administration of AMG145. Patients will be on the study for 2 years and will either be randomised to receive AMG145 for 2 years, or to receive standard of care for a year and then AMG145 for a year after that.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  13/NW/0363

• Date of REC Opinion

  23 May 2013

• REC opinion

  Favourable Opinion