NCT01879319

Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen

A Multicenter, 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 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (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 a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).

Conditions

• Primary Hypercholesterolemia
• Mixed Dyslipidemia

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab AMD	Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.
BIOLOGICAL	Evolocumab AI/pen	Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.

Timeline

• Start date: 2013-07-11
• Primary completion: 2013-11-15
• First posted: 2013-06-17
• Last updated: 2022-11-30
• Results posted: 2015-12-23

Locations

27 sites across 2 countries: United States, Canada