Osler 2

A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145-2

Osler 2 [NCT01854918]

Description: This study will contribute to the evaluation of long-term safety, tolerability and efficacy of AMG 145 in subjects with hyperlipidemia and subjects with mixed dyslipidemia.

 

Drug: AMG 145 and standard of care; Other: Standard of care

Primary Investigator: Bailey

Drug/Device Information
To characterize the safety and tolerability of long-term administration of AMG 145
AMG 145-human monoclonal (Ig)G2 that binds PCSK9 to lower LDL-C
Open label extension study randomized 2:1 to AMG 145 + standard of care (SOC) or SOC-alone
Amgen
Major Inclusion and Exclusion
Complete a qualifying AMG 145 parent study protocol while still on assigned study medication
No medical condition that requires lipid measurement and/or adjustment of background lipid therapy during the first 12 weeks