Extension Study with AMG 145 in Subjects With Hypercholesterolemia

• Research type

  Research Study

• Full title

  A Multicenter, controlled, Open-Label Extension (OLE) Study To Assess the Long-Term Safety and Efficacy of AMG 145

• IRAS ID

  83980

• Contact name

  Michael Feher

• Sponsor organisation

  Amgen Ltd.

• Eudract number

  2011-001915-29

• ISRCTN Number

  not known

• Research summary

  This is a multicentre, controlled, open-label extension study to assess the long-term safety and efficacy of AMG 145. Patients in the UK will be invited to enter this study after completing previous protocol 20090158 and following completion of a consent form for this extension protocol. They will be randomised 2:1 to either AMG145 (420mg) every 4 weeks plus standard of care or standard of care alone. Study visits occur 4 weekly for 1 year for all subjects. The end of study visit for the qualifying protocol will serve as the screening visit for the study, unless entry into this protocol is delayed by more than 3 days then screening procedures will need to be repeated. Patients randomised to AMG 145 will receive 6 mL of study drug subcutaneously once every 4 weeks for 1 year and will complete the study with the end-of-study (EOS) visit. Patients randomised to standard of care will continue with their current treatment without AMG145. The study includes quarterly blood sample collection including fasting lipids and biomarkers.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/1974

• Date of REC Opinion

  20 Dec 2011

• REC opinion

  Favourable Opinion