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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Primary Hypercholesterolemia, Mixed Dyslipidemia

Intervention / Treatment
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* Biological: Evolocumab Pre-filled Syringe
* Biological: Evolocumab AI/pen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evolocumab PFS<br>Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. | Biological: Evolocumab Pre-filled Syringe<br>* Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.<br>* Other names: Repatha;|
| Experimental: Evolocumab AI/pen<br>Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. | Biological: Evolocumab AI/pen<br>* Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.<br>* Other names: Repatha;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 2 and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in LDL-C at Week 6 |  | Baseline and Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LDL-C, triglycerides, high cholesterol