Hypercholesterolaemia MedDRA version: 19.0 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 19.0 Level: LLT Classification code 10057099 Term: Heterozygous familial hypercholesterolaemia System Organ Class: 100000004850
Conditions
Interventions
Product Code: AMG 145
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Evolocumab
Current Sponsor code: AMG 145
Other de
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Complete a qualifying AMG 145 parent study protocol 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 918 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 406
Exclusion criteria
Exclusion criteria: - 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 - 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 - Experienced a treatment-related serious adverse event that led to IP discontinuation in the parent study - 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 nvestigator. - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the safety and tolerability of long-term administration of AMG 145;Secondary Objective: To characterize the efficacy of long-term administration of AMG 145 as assessed by LDL-C and non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, and ApoB/Apolipoprotein A-1 (ApoA1) ratio in subjects with hypercholesterolemia;Primary end point(s): Subject incidence of adverse events;Timepoint(s) of evaluation of this end point: Subject incidence of adverse events: Day 1, at each interval visit (every 4 weeks) and at the end of study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): LDL-C non-HDL-C ApoB Total cholesterol/HDL-C ratio ApoB/ApoA1 ratio ; Timepoint(s) of evaluation of this end point: LDL-C at week 24 and week 52 non-HDL-C at week 24 and week 52 ApoB at week 24 and week 52 Total cholesterol/HDL-C ratio at week 24 and week 52 ApoB/ApoA1 ratio at week 24 and week 52 | — |
Countries
Australia, Belgium, Canada, Czech Republic, Denmark, European Union, Finland, Germany, Hong Kong, Hungary, Netherlands, Norway, Singapore, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed