Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Biological: Evolocumab

• Registration Number: NCT02304484
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-07
• Study Start: 2014-11-24
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-12-02
• Primary Completion: 2018-03-09
• Study Completion: 2018-03-09
• Status Verified: 2019-02
• Results First Submitted: 2019-02-27
• Results First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-27
• Results First Posted: 2019-03-19
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

• Completed week 80 of study 20120153 (NCT01813422).

Exclusion Criteria

• Did not complete investigational product 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evolocumab	Evolocumab	Participants received 420 mg evolocumab once a month for up to 2 years.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.	The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE.; An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser \[AMD\]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)	Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128

Trial Locations

Locations (1)

Research Site; 🇬🇧 Newcastle Upon Tyne, United Kingdom