NCT01879319

Brief Summary

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).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
2 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

July 11, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 23, 2015

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

June 13, 2013

Results QC Date

September 11, 2015

Last Update Submit

November 4, 2022

Conditions

Primary HypercholesterolemiaMixed Dyslipidemia

Keywords

LDL-C, triglycerides, high cholesterol

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Full Administration of Evolocumab at Both 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.

    Weeks 4 and 8

Secondary Outcomes (1)

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

    Baseline and Weeks 10 and 12

Study Arms (2)

Evolocumab AMD

EXPERIMENTAL

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.

Biological: Evolocumab AMD

Evolocumab AI/pen

EXPERIMENTAL

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.

Biological: Evolocumab AI/pen

Interventions

Evolocumab AMDBIOLOGICAL

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

Also known as: AMG 145, Repatha
Evolocumab AMD
Evolocumab AI/penBIOLOGICAL

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

Also known as: AMG-145, Repatha
Evolocumab AI/pen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting LDL-C at screening \> 85 mg/dL
  • Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Phoenix, Arizona, 85020, United States

Location

Research Site

Encino, California, 91436, United States

Location

Research Site

Thousand Oaks, California, 91360, United States

Location

Research Site

Tustin, California, 92780, United States

Location

Research Site

Ventura, California, 93003, United States

Location

Research Site

Port Charlotte, Florida, 33952, United States

Location

Research Site

Saint Augustine, Florida, 32086, United States

Location

Research Site

Atlanta, Georgia, 30328, United States

Location

Research Site

Atlanta, Georgia, 30342, United States

Location

Research Site

Gainesville, Georgia, 30501, United States

Location

Research Site

Lexington, Kentucky, 40504, United States

Location

Research Site

Lewiston, Maine, 04240, United States

Location

Research Site

Ayer, Massachusetts, 01432, United States

Location

Research Site

Manlius, New York, 13104, United States

Location

Research Site

Cadiz, Ohio, 43907, United States

Location

Research Site

Marion, Ohio, 43302, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Research Site

Lansdale, Pennsylvania, 19446, United States

Location

Research Site

Jackson, Tennessee, 38305, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Austin, Texas, 78731, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Research Site

Burnaby, British Columbia, V5G 1T4, Canada

Location

Research Site

London, Ontario, N5W 6A2, Canada

Location

Research Site

Sarnia, Ontario, N7T 4X3, Canada

Location

Research Site

Toronto, Ontario, M9V 4B4, Canada

Location

Research Site

Pointe-Claire, Quebec, H9R 3J1, Canada

Location

Related Publications (4)

  • 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.

    PMID: 28717862BACKGROUND

  • 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.

    PMID: 29353350BACKGROUND

  • 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.

    PMID: 28249876BACKGROUND

  • Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.

    PMID: 32114889BACKGROUND

Related Links

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

evolocumab

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 17, 2013

Study Start

July 11, 2013

Primary Completion

November 15, 2013

Last Updated

November 30, 2022

Results First Posted

December 23, 2015

Record last verified: 2022-11

Locations

US(22)CA(5)