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Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen

NCT01849497 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2018-11-29

Study results available
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Summary

The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.

Conditions

  • Primary Hypercholesterolemia
  • Mixed Dyslipidemia

Interventions

BIOLOGICAL

Evolocumab Pre-filled Syringe

Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.

BIOLOGICAL

Evolocumab AI/pen

Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-04-18
Primary Completion
2013-09-02

Countries

  • United States
  • Canada

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 NCT01849497 on ClinicalTrials.gov