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

Conditions

• Mixed Dyslipidemia
• Primary Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Evolocumab Pre-filled Syringe — BIOLOGICAL
  Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
• Evolocumab AI/pen — BIOLOGICAL
  Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.

Study Details

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.

Key Dates

Start date

Apr 18, 2013

Status verified

Nov 2018

Primary completion

Sep 2, 2013

Study Design

Enrollment

149 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Evolocumab PFS
  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.
• Experimental: 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.

Primary Outcome Measure

Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 [ Time Frame: Week 2 and Week 4 ]

Locations (21)

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