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OpenTrials
Completed

NCT Number: NCT01849497

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

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.

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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, London, Ontario, 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 Pre-filled Syringe

Biological

Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.

Other names: AMG 145, Repatha

Evolocumab AI/pen

Biological

Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.

Other names: AMG 145, Repatha

Primary outcomes

  1. Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4

    Time frame: 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 outcomes

  1. Percent Change From Baseline in LDL-C at Week 6

    Time frame: Baseline and Week 6

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multi-center, 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 Prefilled Syringe or a Prefilled Autoinjector/Pen

Important dates

Study start
2013
Primary completion
2013
First posted
May 8, 2013
Registry last updated
Nov 29, 2018

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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