This study is being done to learn more about long-term use of evolocumab, safety and tolerability, and whether its chronic administration is associated to any side effects

Phase 1

• Conditions: Dyslipidemia; MedDRA version: 21.0Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861; MedDRA version: 21.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-004066-26-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Study Completion: 2022-03-04
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

- Subject has provided informed consent prior to initiation of any study specific activities/procedures

- Subject had 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 880
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 720

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 likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures 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

- Subject has known sensitivity to any of the active substances or excipients (eg. carboxymethylcellulose) to be administered during dosing

- Females who are pregnant or breastfeeding or planning to become
pregnant or breastfeed during treatment and for an additional 15 weeks after treatment discontinuation

- Female subjects of childbearing potential unwilling to use one acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of protocol-required therapies.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br><br>- To describe the effects of long-term administration of evolocumab in subjects achieving LDL-C 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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Percent change of LDL-C from baseline at each scheduled yearly visit<br><br>- Achievement of an LDL-C < 40 mg/dL(1.03 mmol/L) at each scheduled yearly visit;Timepoint(s) of evaluation of this end point: Baseline and each scheduled yearly visit