NCT01849497

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

A Multi-center, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a Prefilled Syringe or a Prefilled Autoinjector/Pen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-04-18
• Primary completion: 2013-09-02
• First posted: 2013-05-08
• Last updated: 2018-11-29
• Results posted: 2015-10-09

Locations

26 sites across 2 countries: United States, Canada