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

Amgen

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Biological: Evolocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02304484

2014-001524-30 (EudraCT Number)

20140128

Details and patient eligibility

About

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.

Enrollment: 770 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

770 participants in 1 patient group

Evolocumab

Experimental group

Description:

Participants received 420 mg evolocumab once a month for up to 2 years.

Treatment:

Biological: Evolocumab