Study to assess the long term safety and efficacy of evolocumab in patients with a waxy substance (plaque) in the arteries of the heart.

• Register: EUCTR
• Last refreshed on: 11 June 2018
• Main ID: EUCTR2014-001524-30-NL
• Date of registration: 23/02/2015
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: Study to assess the long term safety and efficacy of evolocumab in patients with a waxy substance (plaque) in the arteries of the heart.
• Scientific title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
• Date of first enrolment: 17/03/2015
• Target sample size: 642
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001524-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Korea, Democratic People's Republic of, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects will be eligible for the study if they completed study 20120153.
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 494
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 148

Exclusion criteria:
- Did not complete IP in the parent study 20120153
- Have an unstable medical condition, in the judgment of the investigator
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding evolocumab parent study), or less than 30 days since ending another
investigational device or drug study(s),or receiving other investigational agent(s)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Hypercholesterolaemia
MedDRA version: 17.1 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Product Name: Evolocumab
Product Code: AMG 145
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Evolocumab
Other descriptive name: AMG145
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 140-

Product Name: Evolocumab
Product Code: AMG 145
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: Evolocumab
Other descriptive name: AMG145
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Primary end point(s): Subject incidence of adverse events

Main Objective: To characterize the safety and tolerability of long-term administration of
evolocumab in subjects with known coronary artery disease and hypercholesterolemia

Secondary Objective: To characterize the efficacy of long-term administration of evolocumab as assessed by LDL-C in
subjects with known coronary artery disease and hypercholesterolemia

Timepoint(s) of evaluation of this end point: Day 1, weeks 4, 12, 24, 36, 48, 52, 76 and 104

Secondary Outcome(s)

Secondary end point(s): LDL-C

Timepoint(s) of evaluation of this end point: Week 52

Secondary ID(s)

2014-001524-30-HU

20140128

Source(s) of Monetary Support

Amgen Inc.