EUCTR2015-004780-36-PL进行中（未招募）1 期
A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- •-Subject has 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 2800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2200
排除标准
- •- 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 not likely to be available to complete protocol required study
- •visits or procedures, and/or to comply with required study 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.
- •-Known sensitivity to any of the active substances or excipients (eg.
- •sodium acetate) to be administered during dosing.
- •- Female subject is pregnant or breast feeding, planning to become
- •pregnant or planning to breastfeed during treatment with evolocumab
- •and within 15 weeks after the end of treatment with evolocumab.
- •- Female subject of childbearing potential not willing to use an
- •acceptable method(s) of effective birth control during treatment with
- •evolocumab and for an additional 15 weeks after the end of treatment
- •with IP. Female subjects of nonchildbearing potential are not required to use contraception during the study and include those who have had a
- •hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or who
- •are postmenopausal. Postmenopausal is defined as 12 months of
- •spontaneous and continuous amenorrhea in a female = 55 years old; or
- •age < 55 years but no spontaneous menses for at least 2 years; or age <
- •55 years and spontaneous menses within the past 1 year, but currently
- •amenorrheic (eg, spontaneous or secondary to hysterectomy), and with
- •postmenopausal gonadotropin levels (luteinizing hormone and follicle
- •stimulating hormone levels > 40 IU/L) or postmenopausal estradiol
- •levels (<5 ng/dL) or according to the definition of postmenopausal
- •range for the laboratory involved. Acceptable methods of effective birth control include: true sexual abstinence (when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg.,calendar, ovulation, symptothermal, post-ovulation methods),
- •declaration of abstinence for the duration of a trial, and withdrawal are
- •not acceptable methods of contraception]), surgical contraceptive
- •methods (vasectomy or bilateral tubal ligation), use of hormonal birth
- •control methods (oral, intravaginal, transdermal, injectable, or
- •implantable), intrauterine devices (IUDs), intrauterine hormonal
- •releasing system (IUS) or two (2) barrier methods (each partner must
- •use one barrier method) and at least one of barrier methods must incude spermicide – males must use a condom; females must choose either aDiaphragm, OR Cervical cap, OR Contraceptive sponge (a female condom is not an option because of the risk of tearing when both partners use a condom). If spermicide is not available in the country or region, the two barrier method without spermicide is acceptable.
- •Note: Additional medications given during treatment with evolocumab
- •may alter the contraceptive requirements. These additional medications may require the use of highly effective methods of contraception and/or an increase in the length of time that contraception is to be
研究者
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