Study to assess the long term safety and efficacy of AMG 145 in patients with high concentrations of lipids in the blood

Phase 1

• Conditions: Primary hyperlipidaemia and mixed dyslipidaemia; MedDRA version: 19.0 Level: PT Classification code 10058108 Term: Dyslipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 19.0 Level: LLT Classification code 10016205 Term: Familial hyperlipidaemia System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-004357-83-HU
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-14
• Study Completion: 2018-05-31
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3681

Inclusion Criteria

Subjects will be eligible for the study if they complete a qualifying AMG 145 parent study protocol while still on assigned study medication.
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 3232
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1196

Exclusion Criteria

Subjects will be ineligible for the study if they fulfill any of the following criteria:
- Discontinued assigned study drug during the qualifying study for any reason including an adverse event or serious adverse event
- Female subject is not willing to use an acceptable method(s) of effective birth control during treatment with investigational product (IP) and for an additional 15 weeks after the end of treatment with IP. Female subjects, who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or who are postmenopausal, are not required to use contraception
o Menopause 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 (e.g., 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
o Acceptable methods of effective birth control include: 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 (pills, shots, implants or patches), intrauterine devices (IUDs), or two (2) barrier methods (each partner must use one barrier
method) with spermicide – males must use a condom with spermicide; females must choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide. Note: Additional medications given during treatment with evolocumab may alter the contraceptive requirements. These additional medications may require an increase in the number of contraceptive methods and/or length of time that contraception is to be utilized after the last dose of protocol-required therapies. The investigator is to discuss these contraceptive changes with the study subject.
- Female subject is pregnant or breast feeding, planning to become pregnant or planning to breastfeed during treatment with IP and/ or within 15 weeks after the end of treatment with IP.
- Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, inability or unwillingness to adhere to the protocol)
- Disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements
- Have an unstable medical condition, in the judgment of the investigator.
- Subject’s medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy during the first 12 weeks of study participation
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding AMG 145 parent study), or less than 30 days since ending another investigationa

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified