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 hyperlipidemia and mixed dyslipidemia; MedDRA version: 16.0 Level: PT Classification code 10058108 Term: Dyslipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 16.0 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-ES
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-26
• 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 2565
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 950

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 at least one highly effective method of birth control during treatment and for an additional 15 weeks after the end of treatment unless subject is sterilized or postmenopausal;
- menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female ? 55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle-stimulating hormone level > 40 IU/L (or according to the definition of postmenopausal range for the laboratory involved) in a female < 55 years old unless the subject has undergone bilateral oophorectomy.
- Highly effective methods of birth control include abstinence, birth control pills, shots, implants, or patches, intrauterine devices (IUDs), sexual activity with a male partner who has had a vasectomy, condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide.
- Subject is pregnant or breast feeding, or might become pregnant during treatment and/ or within 15 weeks after the end of treatment
- 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 investigational device or drug study(s),or receiving other investigational agent(s)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the safety and tolerability of long-term administration of AMG 145;Secondary Objective: To characterize the long-term administration of AMG 145 as assessed by low density lipoprotein cholesterol (LDL-C) in subjects with primary hyperlipidaemia and subjects with mixed dyslipidaemia;Primary end point(s): Subject incidence of adverse events;Timepoint(s) of evaluation of this end point: The timepoints vary depending on whether the subject is on the QM or Q2W regimen and has prior experience of self-injection. The following are all the potential timepoints but please refer to the protocol for further details: Day 1, weeks 2, 4, 8, 12, 24, 44, 46, 48, 50, 52, 56, at every quarterly visit, weeks 100, 102, 104, 108 or early termination.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): ? Percent change from baseline in LDL-C at week 48 and week 104<br> ? Change from baseline in LDL-C at week 48 and week 104<br> ;Timepoint(s) of evaluation of this end point: Baseline (day 1) and weeks 48 and 104