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

NCT02304484 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2019-03-19

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection once a month

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-24
Primary Completion
2018-03-09
Completion
2018-03-09

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02304484 on ClinicalTrials.gov