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

Phase 3

Completed

• Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemia
• Interventions: Biological: Evolocumab AI/pen; Biological: Evolocumab AMD

• Registration Number: NCT01879319
• Lead Sponsor: Amgen

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-17
• Study Start: 2013-07-11
• Primary Completion: 2013-11-15
• Disposition First Submitted: 2014-05-02
• Disposition First Submitted QC: 2014-05-02
• Disposition First Posted: 2014-05-20
• Results First Submitted: 2015-09-11
• Results First Submitted QC: 2015-11-19
• Results First Posted: 2015-12-23
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evolocumab AI/pen	Evolocumab AI/pen	Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
Evolocumab AMD	Evolocumab AMD	Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇨🇦 Pointe-Claire, Quebec, Canada