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

Primary Purpose

Primary Hypercholesterolemia, Mixed Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab Pre-filled Syringe
Evolocumab AI/pen
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia focused on measuring LDL-C, triglycerides, high cholesterol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Evolocumab PFS

Evolocumab AI/pen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 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 Outcome Measures

Percent Change From Baseline in LDL-C at Week 6

Full Information

First Posted
April 1, 2013
Last Updated
November 1, 2018
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01849497
Brief Title
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 18, 2013 (Actual)
Primary Completion Date
September 2, 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia, Mixed Dyslipidemia
Keywords
LDL-C, triglycerides, high cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab PFS
Arm Type
Experimental
Arm Description
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.
Arm Title
Evolocumab AI/pen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Evolocumab Pre-filled Syringe
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
Intervention Type
Biological
Intervention Name(s)
Evolocumab AI/pen
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.
Primary Outcome Measure Information:
Title
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4
Description
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.
Time Frame
Week 2 and Week 4
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C at Week 6
Time Frame
Baseline and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Research Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Research Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Research Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Hammond
State/Province
Indiana
ZIP/Postal Code
46320
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Research Site
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Research Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Research Site
City
Cadiz
State/Province
Ohio
ZIP/Postal Code
43907
Country
United States
Facility Name
Research Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Research Site
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97123
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8V 3X8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Research Site
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5P5
Country
Canada
Facility Name
Research Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28717862
Citation
Boccara F, Dent R, Ruilope L, Valensi P. Practical Considerations for the Use of Subcutaneous Treatment in the Management of Dyslipidaemia. Adv Ther. 2017 Aug;34(8):1876-1896. doi: 10.1007/s12325-017-0586-8. Epub 2017 Jul 17.
Results Reference
background
PubMed Identifier
28249876
Citation
Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.
Results Reference
background
PubMed Identifier
29353350
Citation
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Results Reference
background
PubMed Identifier
27066336
Citation
Dent R, Joshi R, Stephen Djedjos C, Legg J, Elliott M, Geller M, Meyer D, Somaratne R, Recknor C, Weiss R. Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting. Springerplus. 2016 Mar 9;5:300. doi: 10.1186/s40064-016-1892-3. eCollection 2016.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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