Primary HypercholesterolemiaPhase 3NCT01849497

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

A Phase 3 study testing Evolocumab Pre-filled Syringe and Evolocumab AI/pen in people with Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Amgen at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Primary Hypercholesterolemia, Mixed Dyslipidemia
What is being tested?: Evolocumab Pre-filled Syringe and Evolocumab AI/pen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 26 sitesin 2 countries
Study dates: 18 Apr 2013to 2 Sep 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

26 sites in 2 countries.

Country

City, postcode or hospital

26 sites in 2 countries

United States21 sites

Research Site
Atlanta, Georgia, 30328
Research Site
Atlanta, Georgia, 30342
Research Site
Auburn, Maine, 04210
Research Site
Cadiz, Ohio, 43907
Research Site
Dallas, Texas, 75231
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Encino, California, 91436
Research Site
Hammond, Indiana, 46320
Research Site
Hillsboro, Oregon, 97123
Research Site
Houston, Texas, 77074
Research Site
Jackson, Tennessee, 38305
Research Site
Lansdale, Pennsylvania, 19446
Research Site
Manlius, New York, 13104
Research Site
Marion, Ohio, 43302
Research Site
Miami, Florida, 33173
Research Site
Port Charlotte, Florida, 33952
Research Site
Rapid City, South Dakota, 57701
Research Site
Syracuse, New York, 13210
Research Site
Thousand Oaks, California, 91360
Research Site
Ventura, California, 93003
Research Site
Westlake Village, California, 91361

Other trials in United States

Canada5 sites

Research Site
London, Ontario, N5W 6A2
Research Site
Pointe-Claire, Quebec, H9R 3J1
Research Site
Toronto, Ontario, M8V 3X8
Research Site
Toronto, Ontario, M9V 4B4
Research Site
Woodstock, Ontario, N4S 5P5

Other trials in Canada

About this study

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

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.

Conditions: Primary Hypercholesterolemia, Mixed Dyslipidemia
Being tested: Evolocumab Pre-filled Syringe, Evolocumab AI/pen
Keywords: LDL-C, triglycerides, high cholesterol
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evolocumab Pre-filled SyringeBiological
Also called AMG 145, Repatha
Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
Evolocumab AI/penBiological
Also called AMG 145, Repatha
Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.

Study groups in NCT01849497
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Evolocumab AI/pen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 2 and Week 4

Secondary outcomes (1)

Percent Change From Baseline in LDL-C at Week 6
Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 20132 Sep 2013

First posted8 May 2013 (estimated)
Study start18 Apr 2013
Primary completion2 Sep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01849497
Sponsor's protocol ID: 20120348
Status last verified: Nov 2018
First submitted: 1 Apr 2013
Last updated: 29 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28717862
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.
PubMed 28249876
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.
PubMed 29353350
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.
PubMed 27066336

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01849497
Acronym / sponsor ID: 20120348
Conditions: Primary Hypercholesterolemia, Mixed Dyslipidemia
Keywords: LDL-C, triglycerides, high cholesterol
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 18 Apr 2013 (actual)
Primary completion: 2 Sep 2013 (actual)
First posted: 8 May 2013 (estimated)
Results: Posted 9 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Evolocumab PFS	Experimental	Biological: Evolocumab Pre-filled SyringeParticipants 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.
Evolocumab AI/pen	Experimental	Biological: Evolocumab AI/penParticipants 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Evolocumab Pre-filled SyringeAlso: AMG 145, RepathaEvolocumab subcutaneous injection via a single use, disposable pre-filled syringe.	Biological	Evolocumab PFS
Evolocumab AI/penAlso: AMG 145, RepathaEvolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.	Biological	Evolocumab AI/pen

Primary outcome

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.

1 secondary outcome

Percent Change From Baseline in LDL-C at Week 6
Time frame: Baseline and Week 6

Results and safety

Results posted to the registry on 9 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evolocumab PFS	75	74
Evolocumab AI/Pen	74	70

Primary outcome: Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4

Time frame: Week 2 and Week 4. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Evolocumab PFS n = 75	Evolocumab AI/Pen n = 74
Value	96.0 (88.9 to 98.6)	89.2 (80.1 to 94.4)

Evolocumab PFS vs Evolocumab AI/Pen: Treatment Difference: -6.8 (95% CI -16.3 to 2.0)

Population analysed: Full analysis set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose of study drug until 28 days after last study drug administration (up to 8 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evolocumab PFS	3 of 75 (4%)	4 of 75 (5.3%)	Not reported
Evolocumab AI/Pen	2 of 74 (2.7%)	2 of 74 (2.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28717862Boccara 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.
Background: PubMed 28249876Toth 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.
Background: PubMed 29353350Kasichayanula 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.
Derived from this study: PubMed 27066336Dent 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Primary Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

26 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab Pre-filled Syringe and Evolocumab AI/pen in people with Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Amgen at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 (time frame: Week 2 and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01849497, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.