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

NCT ID: NCT01849497

Last Updated: 2018-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-18

Brief Summary

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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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Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

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Detailed Description

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Conditions

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Primary Hypercholesterolemia Mixed Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Evolocumab Pre-filled Syringe

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

Evolocumab AI/pen

Intervention Type BIOLOGICAL

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

Interventions

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Evolocumab Pre-filled Syringe

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

Intervention Type BIOLOGICAL

Evolocumab AI/pen

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

Intervention Type BIOLOGICAL

Other Intervention Names

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AMG 145 Repatha AMG 145 Repatha

Eligibility Criteria

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Inclusion Criteria

* Fasting LDL-C at screening \> 85 mg/dL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Encino, California, United States

Site Status

Research Site

Thousand Oaks, California, United States

Site Status

Research Site

Ventura, California, United States

Site Status

Research Site

Westlake Village, California, United States

Site Status

Research Site

Miami, Florida, United States

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Research Site

Port Charlotte, Florida, United States

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Research Site

Atlanta, Georgia, United States

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Research Site

Atlanta, Georgia, United States

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Research Site

Hammond, Indiana, United States

Site Status

Research Site

Auburn, Maine, United States

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Research Site

Manlius, New York, United States

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Research Site

Syracuse, New York, United States

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Research Site

Cadiz, Ohio, United States

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Research Site

Marion, Ohio, United States

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Research Site

Hillsboro, Oregon, United States

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Research Site

Duncansville, Pennsylvania, United States

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Research Site

Lansdale, Pennsylvania, United States

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Research Site

Rapid City, South Dakota, United States

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Research Site

Jackson, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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London, Ontario, Canada

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Research Site

Toronto, Ontario, Canada

Site Status

Research Site

Toronto, Ontario, Canada

Site Status

Research Site

Woodstock, Ontario, Canada

Site Status

Research Site

Pointe-Claire, Quebec, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type BACKGROUND
PMID: 28717862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28249876 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29353350 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27066336 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20120348

Identifier Type: -

Identifier Source: org_study_id

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