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Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders

NCT01624142 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-05-28

Study results available
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Summary

A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

Conditions

  • Severe Familial Hypercholesterolemia

Interventions

BIOLOGICAL

Evolocumab

Evolocumab was administered by subcutaneous injection either once a month (QM) or once every two weeks (Q2W).

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-01
Primary Completion
2018-05-11
Completion
2018-05-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Greece
  • Hong Kong
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Netherlands
  • New Zealand
  • South Africa
  • Spain
  • 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 NCT01624142 on ClinicalTrials.gov