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OpenTrials
Completed

NCT Number: NCT01879319

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

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).

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Key information

Conditions

Primary Hypercholesterolemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Mixed Dyslipidemia Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Burnaby, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evolocumab AMD

Biological

Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.

Other names: AMG 145, Repatha

Evolocumab AI/pen

Biological

Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.

Other names: AMG-145, Repatha

Primary outcomes

  1. Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8

    Time frame: 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 outcomes

  1. Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, 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 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.

Important dates

Study start
2013
Primary completion
2013
First posted
Jun 17, 2013
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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