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Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

NCT01588496 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2018-11-29

Study results available
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Summary

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Conditions

  • Homozygous Familial Hypercholesterolemia

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection

DRUG

Placebo

Administered by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-05
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Hong Kong
  • Italy
  • Lebanon
  • Netherlands
  • New Zealand
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT01588496 on ClinicalTrials.gov