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

November 1, 2018 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
      • Toronto, Ontario, Canada, M8V 3X8
        • Research Site
      • Woodstock, Ontario, Canada, N4S 5P5
        • Research Site
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
  • United States
    • California
      • Encino, California, United States, 91436
        • Research Site
      • Thousand Oaks, California, United States, 91360
        • Research Site
      • Ventura, California, United States, 93003
        • Research Site
      • Westlake Village, California, United States, 91361
        • Research Site
    • Florida
      • Miami, Florida, United States, 33173
        • Research Site
      • Port Charlotte, Florida, United States, 33952
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
      • Atlanta, Georgia, United States, 30342
        • Research Site
    • Indiana
      • Hammond, Indiana, United States, 46320
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
    • New York
      • Manlius, New York, United States, 13104
        • Research Site
      • Syracuse, New York, United States, 13210
        • Research Site
    • Ohio
      • Cadiz, Ohio, United States, 43907
        • Research Site
      • Marion, Ohio, United States, 43302
        • Research Site
    • Oregon
      • Hillsboro, Oregon, United States, 97123
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
      • Lansdale, Pennsylvania, United States, 19446
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Evolocumab Pre-filled Syringe
Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
Other Names:
  • Repatha
  • AMG 145
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.
Biological: Evolocumab AI/pen
Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 2 and Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in LDL-C at Week 6
Time Frame: Baseline and Week 6
Baseline and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 18, 2013

Primary Completion (ACTUAL)

September 2, 2013

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (ESTIMATE)

May 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120348

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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