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

A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001524-30-GB

Enrollment

642

Registered

2015-02-04

Start date

2015-08-10

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia MedDRA version: 19.0 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Evolocumab Product Code: AMG 145 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Evolocumab

Eligibility

Sex/Gender

All

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
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 ;Primary end point(s): Subject incidence of adverse events;Timepoint(s) of evaluation of this end point: Day 1, weeks 4, 12, 24, 36, 48, 52, 76 and 104	—

Measure

Time frame

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 ;Primary end point(s): Subject incidence of adverse events;Timepoint(s) of evaluation of this end point: Day 1, weeks 4, 12, 24, 36, 48, 52, 76 and 104

—

Secondary

Measure	Time frame
Secondary end point(s): LDL-C ;Timepoint(s) of evaluation of this end point: Week 52	—

Countries

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

Public ContactIHQ Medical Info - Clinical Trials

Amgen (EUROPE) GmbH

MedinfoInternational@amgen.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026