Klinische Forschung

Multizentrisch, KSSG als teilnehmendes Zentrum

Abgeschlossen

2013

2017

Industrie

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