This trial is active, not recruiting.

Condition hypercholesterolemia
Treatment evolocumab
Phase phase 3
Sponsor Amgen
Start date November 2014
End date July 2018
Trial size 770 participants
Trial identifier NCT02304484, 2014-001524-30, 20140128


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
single arm all subjects receive Evolocumab
All subjects will receive open-label evolocumab for approximately 2 years (or until the investigator's recommendation of discontinuation, Amgen's recommendation of discontinuation, the subject's decision to discontinue for any reason, or until an administrative decision is made to end the study).

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: after all subjects complete week 52

Secondary Outcomes

Low density lipoprotein cholesterol (LDL-C) at week 52
time frame: after week 52 for all subjects

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: -Completed week 80 of study 20120153. Exclusion Criteria: - Did not complete IP in the 20120153 parent study - 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 (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Additional Information

Official title A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Amgen.