A study assessing if long-term use of evolocumab will be safe, well tolerated, and whether it causes any side effects.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2800

Inclusion Criteria

- 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

Exclusion Criteria

- 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.
carboxymethylcellulose) 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 incre

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 10/17/2023

A study assessing if long-term use of evolocumab will be safe, well tolerated, and whether it causes any side effects.

Recruitment & Eligibility

Study & Design

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