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

Phase 3

Completed

• Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia
• Interventions: Biological: Evolocumab AI/pen; Biological: Evolocumab Pre-filled Syringe

• Registration Number: NCT01849497
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-01
• Study Start: 2013-04-18
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Primary Completion: 2013-09-02
• 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: 2015-09-11
• Results First Posted: 2015-10-09
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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 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.
Evolocumab PFS	Evolocumab Pre-filled Syringe	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4	Week 2 and Week 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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-C at Week 6	Baseline and Week 6

Trial Locations

Locations (1)

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