NCT01849497

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.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
2 countries

26 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

April 1, 2013

Completed
17 days until next milestone

Study Start

First participant enrolled

April 18, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 9, 2015

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

April 1, 2013

Results QC Date

September 11, 2015

Last Update Submit

November 1, 2018

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 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.

    Week 2 and Week 4

Secondary Outcomes (1)

  • Percent Change From Baseline in LDL-C at Week 6

    Baseline and Week 6

Study Arms (2)

Evolocumab PFS

EXPERIMENTAL

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 AI/pen

EXPERIMENTAL

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

Interventions

Evolocumab Pre-filled SyringeBIOLOGICAL

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

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

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

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

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 (26)

Research Site

Encino, California, 91436, United States

Location

Research Site

Thousand Oaks, California, 91360, United States

Location

Research Site

Ventura, California, 93003, United States

Location

Research Site

Westlake Village, California, 91361, United States

Location

Research Site

Miami, Florida, 33173, United States

Location

Research Site

Port Charlotte, Florida, 33952, United States

Location

Research Site

Atlanta, Georgia, 30328, United States

Location

Research Site

Atlanta, Georgia, 30342, United States

Location

Research Site

Hammond, Indiana, 46320, United States

Location

Research Site

Auburn, Maine, 04210, United States

Location

Research Site

Manlius, New York, 13104, United States

Location

Research Site

Syracuse, New York, 13210, United States

Location

Research Site

Cadiz, Ohio, 43907, United States

Location

Research Site

Marion, Ohio, 43302, United States

Location

Research Site

Hillsboro, Oregon, 97123, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Research Site

Lansdale, Pennsylvania, 19446, United States

Location

Research Site

Rapid City, South Dakota, 57701, United States

Location

Research Site

Jackson, Tennessee, 38305, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Research Site

Houston, Texas, 77074, United States

Location

Research Site

London, Ontario, N5W 6A2, Canada

Location

Research Site

Toronto, Ontario, M8V 3X8, Canada

Location

Research Site

Toronto, Ontario, M9V 4B4, Canada

Location

Research Site

Woodstock, Ontario, N4S 5P5, 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

  • 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

  • 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

  • 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.

    PMID: 27066336DERIVED

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

April 1, 2013

First Posted

May 8, 2013

Study Start

April 18, 2013

Primary Completion

September 2, 2013

Last Updated

November 29, 2018

Results First Posted

October 9, 2015

Record last verified: 2018-11

Locations

US(21)CA(5)