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
Interventions
Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: EV
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 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
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. sodium acetate) 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.
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 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percent change of LDL-C from baseline at each scheduled visit - Achievement of an LDL-C < 40 mg/dL(1.03 mmol/L) at each scheduled visit;Timepoint(s) of evaluation of this end point: Baseline and each scheduled visit | — |
Countries
Belgium, Denmark, Germany, Portugal, Sweden
Contacts
Public ContactMedical Information
Amgen GmbH
Outcome results
None listed