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

Amgen164 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Primary Hypercholesterolemia Mixed Dyslipidemia

Interventions

Evolocumab AMDBIOLOGICAL

Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.

Evolocumab AI/penBIOLOGICAL

Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fasting LDL-C at screening \> 85 mg/dL * Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria: * New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Type 1 diabetes or poorly controlled type 2 diabetes * Uncontrolled hypothyroidism or hyperthyroidism

Locations (27)

Research Site

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8

Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.

Time frame: Weeks 4 and 8

Secondary Outcomes

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

Time frame: Baseline and Weeks 10 and 12

Data from ClinicalTrials.gov

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