Dyslipidemia MedDRA version: 21.0 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861 MedDRA version: 21.0 Level: LLT Classification code 10058110 Term: Dyslipidemia System Organ Class: 100000004861
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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. 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the safety and tolerability of long-term administration of evolocumab.;Secondary Objective: - To describe the effects of long-term administration of evolocumab on low density lipoprotein cholesterol (LDL-C) levels. - To describe the effects of long-term administration of evolocumab in subjects achieving LDLC level of < 40 mg/dL (1.03 mmol/L). ;Primary end point(s): Subject incidence of adverse events;Timepoint(s) of evaluation of this end point: 260 weeks (approximately 5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percent change of LDL-C from baseline at each scheduled visits - Achievment of an LDL-C < 40 mg/dL(1.03 mmol/L) at each scheduled visits. ;Timepoint(s) of evaluation of this end point: Baseline and each scheduled visit | — |
Countries
Czechia, Czech Republic, Hungary, Poland, Russian Federation, Slovakia, Ukraine, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen Biotechnologia Sp. z o.o.
Outcome results
None listed