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Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

NCT01854918 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3681

Last updated 2019-06-11

Study results available
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Summary

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Conditions

  • Hyperlipidemia and Mixed Dyslipidemia

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen

DRUG

Standard of Care

Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-04-23
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01854918 on ClinicalTrials.gov