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

Amgen149 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

149

Conditions

Primary Hypercholesterolemia Mixed Dyslipidemia

Interventions

Evolocumab Pre-filled SyringeBIOLOGICAL

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

Evolocumab AI/penBIOLOGICAL

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

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 (26)

Research Site

Encino, California, United States

Outcomes

Primary Outcomes

Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4

Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.

Time frame: Week 2 and Week 4

Secondary Outcomes

Percent Change From Baseline in LDL-C at Week 6

Time frame: Baseline and Week 6

Data from ClinicalTrials.gov

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