A Multicenter, Open-label, Single-arm, Extension Study to AssessLong-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

Amgen Inc0 个研究点目标入组 1,600 人开始时间: 2017年1月3日最近更新: 2022年2月7日

适应症

试验速览

暂无简介。

•- Subject has provided informed consent prior to initiation of any study specific activities/procedures
•- Subject had completed FOURIER while still receiving assigned Investigational Product
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 880
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 720

•- Permanent discontinuation of Investigational Product during FOURIER for any reason including an adverse event or serious adverse event
•-Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded
•- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge
•- History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
•- Subject has known sensitivity to any of the active substances or excipients (eg. sodium acetate) to be administered during dosing
•- Females who are pregnant or breastfeeding or planning to become
•pregnant or breastfeed during treatment and for an additional 15 weeks after treatment discontinuation
•- Female subjects of childbearing potential unwilling to use one acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of protocol-required therapies.

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