Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser 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 AMD — BIOLOGICAL
  Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.
• Evolocumab AI/pen — BIOLOGICAL
  Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.

Study Details

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).

Key Dates

Start date

Jul 11, 2013

Status verified

Nov 2022

Primary completion

Nov 15, 2013

Study Design

Enrollment

164 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ]

Locations (22)

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