AMG 145 20120138 OSLER

Abgeschlossen · 2013 bis 2017

Klinische Forschung
Multizentrisch, KSSG als teilnehmendes Zentrum
This is a multicenter, randomized, controlled, open-label extension study designed to assess the long-term safety and efficacy of AMG 145. Subjects that successfully complete a qualifying protocol and sign informed consent will be randomized 2:1 to one of two groups: AMG 145 + standard of care (SOC) or SOC-alone. Subjects randomized to the treatment group will also be expected to take background lipid lowering therapy and will be able to choose from one of two dose regimens: AMG 145 (140mg) administered every 2 weeks (Q2W) + SOC, or AMG 145 (420mg) administered monthly (QM) + SOC. Subjects randomized to the control group will receive SOC alone for the first 48 weeks of the study. During the first 12 weeks of the study participation, LDL-C will remain blinded and subjects must remain on stable background lipid lowering therapy. Using clinical judgment, the primary investigator or qualified delegate should recommend background lipid lowering therapy the subject can be expected to tolerate: therapy either prescribed to them PRIOR to participation in parent study, or statin or ezetimibe therapy given during parent study. Investigators will be informed if triglycerides are > 1000 mg/dL (11.3 mmol/L) so that appropriate subject follow-up can be initiated if necessary

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

Study Phase: 3
Indication: Primary hyperlipidemia and mixed dyslipidemia
Primary Objective: To characterize the safety and tolerability of long-term administration of
AMG 145
Secondary Objectives:
To characterize efficacy of long-term administration of AMG 145 as assessed by low density
lipoprotein cholesterol (LDL-C) in subjects with primary hyperlipidemia and subjects with mixed
The primary clinical hypothesis is that long-term exposure of AMG 145 will be safe and
well-tolerated in subjects with primary hyperlipidemia and subjects with mixed dyslipidemia.
Primary Endpoint:
Subject incidence of adverse events