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Open Label Study of Long Term Evaluation Against LDL-C Trial

NCT01439880 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1324

Last updated 2022-09-21

Study results available
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Summary

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection

OTHER

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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-07
Primary Completion
2018-06-20
Completion
2018-06-20

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hong Kong
  • Hungary
  • Japan
  • Netherlands
  • Norway
  • Singapore
  • South Africa
  • Spain
  • Sweden
  • 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 NCT01439880 on ClinicalTrials.gov