HyperlipidemiaPhase 2LAPLACENCT01380730

LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

A Phase 2 study testing Evolocumab in people with Hyperlipidemia, run by Amgen at 100 sites in 5 countries.

Completed

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

Trial summary

To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hyperlipidemia
What is being tested?: Evolocumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 631 participants
Where: 100 sitesin 5 countries
Study dates: 1 Jul 2011to 5 Apr 2012
Phase: Phase 2
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

Male or female ≥ 18 to ≤ 80 years of age
On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
Fasting LDL-C ≥ 85 mg/dL
Fasting triglycerides ≤ 400 mg/dL

Who cannot join

Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%)
Uncontrolled hypertension
New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
Uncontrolled cardiac arrhythmia

Trial locations and contacts

100 sites in 5 countries.

Country

City, postcode or hospital

100 sites in 5 countries

United States55 sites

Research Site
Anaheim, California, 92801
Research Site
Auburn, Maine, 04210
Research Site
Bangor, Maine, 04401
Research Site
Birmingham, Alabama, 35294
Research Site
Camp Hill, Pennsylvania, 17011
Research Site
Canton, Ohio, 44708
Research Site
Carmichael, California, 95608
Research Site
Cincinnati, Ohio, 45212
Research Site
Cincinnati, Ohio, 45219
Research Site
Colorado Springs, Colorado, 80909
Research Site
Cortlandt Manor, New York, 10567
Research Site
Dayton, Ohio, 45414
Research Site
Daytona Beach, Florida, 32117
Research Site
Florence, South Carolina, 29501
Research Site
Great Falls, Montana, 59405
Research Site
Green Cove Springs, Florida, 32043
Research Site
Hammond, Indiana, 46320
Research Site
Houston, Texas, 77002
Research Site
Houston, Texas, 77074
Research Site
Indianapolis, Indiana, 46237
Research Site
Iowa City, Iowa, 52242
Research Site
Jackson, Tennessee, 38301
Research Site
Jackson, Tennessee, 38305
Research Site
Kalamazoo, Michigan, 49048
Research Site
Lexington, Kentucky, 40536
Research Site
Littleton, Colorado, 80120
Research Site
Madison, Wisconsin, 53713
Research Site
Malvern, Arkansas, 72104
Research Site
Mansfield, Ohio, 44906
Research Site
Marion, Ohio, 43302
Research Site
Marquette, Michigan, 49855
Research Site
Melbourne, Florida, 32901
Research Site
Miami, Florida, 33143
Research Site
Miami, Florida, 33173
Research Site
Newport Beach, California, 92663
Research Site
Peoria, Illinois, 61614
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Pittsburgh, Pennsylvania, 15216
Research Site
Port Charlotte, Florida, 33952
Research Site
Portland, Maine, 04101
Research Site
Rapid City, South Dakota, 57701
Research Site
Roseville, California, 95747
Research Site
Sandusky, Ohio, 44870
Research Site
Smithfield, North Carolina, 27577
Research Site
Spartanburg, South Carolina, 29302
Research Site
Tacoma, Washington, 98405
Research Site
Tucson, Arizona, 85710
Research Site
Tupelo, Mississippi, 38801
Research Site
Valparaiso, Indiana, 46383
Research Site
Voorhees Township, New Jersey, 08043
Research Site
Westlake Village, California, 91361
Research Site
Williamsville, New York, 14221
Research Site
Winston-Salem, North Carolina, 27103
Research Site
York, Pennsylvania, 17405
Research Site
Ypsilanti, Michigan, 48197

Other trials in United States

Canada22 sites

Research Site
Burnaby, British Columbia, V5G 1T4
Research Site
Cambridge, Ontario, N1R 6V6
Research Site
Gatineau, Quebec, J8Y 6S9
Research Site
Greater Sudbury, Ontario, P3C 5K7
Research Site
Hamilton, Ontario, L8L 2X2
Research Site
Kelowna, British Columbia, V1Y 1V6
Research Site
Lachine, Quebec, H8S 2E4
Research Site
London, Ontario, N5W 6A2
Research Site
London, Ontario, N6A 5K8
Research Site
Longueuil, Quebec, J4N 0C9
Research Site
Newmarket, Ontario, L3Y 5G8
Research Site
Oshawa, Ontario, L1J 2J9
Research Site
Oshawa, Ontario, L1J 2K1
Research Site
Pointe-Claire, Quebec, H9R 3J1
Research Site
Québec, Quebec, G1V 4M6
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
Scarborough Village, Ontario, M1P 2T7
Research Site
Toronto, Ontario, M8V 3X8
Research Site
Toronto, Ontario, M9V 4B4
Research Site
Vancouver, British Columbia, V6Z 1Y6
Research Site
Victoria, British Columbia, V8T 5G1
Research Site
Woodstock, Ontario, N4S 5P5

Other trials in Canada

Czechia10 sites

Research Site
Brno, 603 00
Research Site
Brno, 625 00
Research Site
Brno, 656 91
Research Site
Olomouc, 775 20
Research Site
Prague, 120 00
Research Site
Prague, 140 21
Research Site
Slaný, 274 01
Research Site
Svitavy, 568 25
Research Site
Ústí nad Orlicí, 562 18
Research Site
Znojmo, 669 02

Other trials in Czechia

Hungary10 sites

Research Site
Budapest, 1096
Research Site
Debrecen, 4032
Research Site
Dunaújváros, 2400
Research Site
Eger, 3300
Research Site
Gyula, 5700
Research Site
Kecskemét, 6000
Research Site
Komárom, 2991
Research Site
Mosonmagyaróvár, 9200
Research Site
Szolnok, 5004
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Denmark3 sites

Research Site
Aalborg, 9000
Research Site
Ballerup Municipality, 2750
Research Site
Vejle, 7100

Other trials in Denmark

About this study

Official title: LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects

Conditions: Hyperlipidemia
Being tested: Evolocumab, Placebo to Evolocumab
Keywords: Hypercholesterolemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Medical subject headings: Hyperlipidemias, Hypercholesterolemia, Hypercholesterolemia, Autosomal Dominant, 3

What participants receive

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

EvolocumabBiological
Also called AMG 145, Repatha
Administered by subcutaneous injection
Placebo to EvolocumabOther
Administered by subcutaneous injection

Study groups in NCT01380730
Study group	Role	What they receive
Placebo Q2W	Placebo comparator	Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. Receives: Other: Placebo to Evolocumab
Placebo Q4W	Placebo comparator	Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. Receives: Other: Placebo to Evolocumab
Evolocumab 70 mg Q2W	Experimental	Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. Receives: Biological: Evolocumab
Evolocumab 105 mg Q2W	Experimental	Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. Receives: Biological: Evolocumab
Evolocumab 140 mg Q2W	Experimental	Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. Receives: Biological: Evolocumab
Evolocumab 280 mg Q4W	Experimental	Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Receives: Biological: Evolocumab
Evolocumab 350 mg Q4W	Experimental	Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Receives: Biological: Evolocumab
Evolocumab 420 mg Q4W	Experimental	Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Receives: Biological: Evolocumab

What is being measured

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

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was measured using ultracentrifugation.
Measured: Baseline and Week 12

Secondary outcomes (5)

Change From Baseline in LDL-C at Week 12
LDL-C was measured using ultracentrifugation.
Measured: Baseline and Week 12
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Measured: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Measured: Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Measured: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Measured: Baseline and Week 12

Timeline

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

1 Jul 20115 Apr 2012

First posted27 Jun 2011 (estimated)
Study start1 Jul 2011
Primary completion5 Apr 2012
Study completion5 Apr 2012

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 (3)Papers the sponsor has linked to this study.
Other trials for HyperlipidemiaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 631 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01380730
Sponsor's protocol ID: 20101155
Acronym: LAPLACE
Status last verified: Nov 2022
First submitted: 23 Jun 2011
Last updated: 15 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Giugliano RP, Desai NR, Kohli P, Rogers WJ, Somaratne R, Huang F, Liu T, Mohanavelu S, Hoffman EB, McDonald ST, Abrahamsen TE, Wasserman SM, Scott R, Sabatine MS; LAPLACE-TIMI 57 Investigators. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study. Lancet. 2012 Dec 8;380(9858):2007-17. doi: 10.1016/S0140-6736(12)61770-X. Epub 2012 Nov 6.
PubMed 23141813
Kohli P, Desai NR, Giugliano RP, Kim JB, Somaratne R, Huang F, Knusel B, McDonald S, Abrahamsen T, Wasserman SM, Scott R, Sabatine MS. Design and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2012;35(7):385-91. doi: 10.1002/clc.22014. Epub 2012 Jun 19.
PubMed 22714699
Desai NR, Kohli P, Giugliano RP, O'Donoghue ML, Somaratne R, Zhou J, Hoffman EB, Huang F, Rogers WJ, Wasserman SM, Scott R, Sabatine MS. AMG145, a monoclonal antibody against proprotein convertase subtilisin kexin type 9, significantly reduces lipoprotein(a) in hypercholesterolemic patients receiving statin therapy: an analysis from the LDL-C Assessment with Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition Combined with Statin Therapy (LAPLACE)-Thrombolysis in Myocardial Infarction (TIMI) 57 trial. Circulation. 2013 Aug 27;128(9):962-9. doi: 10.1161/CIRCULATIONAHA.113.001969. Epub 2013 Jul 24.
PubMed 23884353

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

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All Hyperlipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects
ClinicalTrials.gov ID: NCT01380730
Acronym / sponsor ID: LAPLACE / 20101155
Conditions: Hyperlipidemia
Keywords: Hypercholesterolemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 631 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Collaborators: The TIMI Study Group
Study start: 1 Jul 2011 (actual)
Primary completion: 5 Apr 2012 (actual)
Study completion: 5 Apr 2012 (actual)
First posted: 27 Jun 2011 (estimated)
Results: Posted 1 Oct 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Placebo Q2W	Placebo comparator	Other: Placebo to EvolocumabParticipants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Placebo Q4W	Placebo comparator	Other: Placebo to EvolocumabParticipants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Evolocumab 70 mg Q2W	Experimental	Biological: EvolocumabParticipants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 105 mg Q2W	Experimental	Biological: EvolocumabParticipants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 140 mg Q2W	Experimental	Biological: EvolocumabParticipants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 280 mg Q4W	Experimental	Biological: EvolocumabParticipants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 350 mg Q4W	Experimental	Biological: EvolocumabParticipants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 420 mg Q4W	Experimental	Biological: EvolocumabParticipants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Who may qualify

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

Key inclusion criteria (4 listed)

Male or female ≥ 18 to ≤ 80 years of age
On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
Fasting LDL-C ≥ 85 mg/dL
Fasting triglycerides ≤ 400 mg/dL

Key exclusion criteria (5 listed)

Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%)
Uncontrolled hypertension
New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
Uncontrolled cardiac arrhythmia

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
EvolocumabAlso: AMG 145, RepathaAdministered by subcutaneous injection	Biological	Evolocumab 105 mg Q2W, Evolocumab 140 mg Q2W, Evolocumab 280 mg Q4W, Evolocumab 350 mg Q4W, Evolocumab 420 mg Q4W, Evolocumab 70 mg Q2W
Placebo to EvolocumabAdministered by subcutaneous injection	Other	Placebo Q2W, Placebo Q4W

Primary outcome

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation.

5 secondary outcomes

Change From Baseline in LDL-C at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 1 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
Placebo Q2W	78	78
Placebo Q4W	79	79
Evolocumab 70 mg Q2W	79	79
Evolocumab 105 mg Q2W	79	79
Evolocumab 140 mg Q2W	78	77
Evolocumab 280 mg Q4W	79	79
Evolocumab 350 mg Q4W	79	79
Evolocumab 420 mg Q4W	80	80

Primary outcome: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Placebo Q2W n = 78	Placebo Q4W n = 77	Evolocumab 70 mg Q2W n = 79	Evolocumab 105 mg Q2W n = 79	Evolocumab 140 mg Q2W n = 78	Evolocumab 280 mg Q4W n = 79	Evolocumab 350 mg Q4W n = 79	Evolocumab 420 mg Q4W n = 80
Value	2.76 (2.39)	-0.98 (2.51)	-39.06 (2.39)	-57.48 (2.39)	-63.34 (2.40)	-42.82 (2.52)	-50.98 (2.51)	-51.31 (2.53)

Placebo Q2W vs Evolocumab 140 mg Q2W: LS Mean Treatment Difference: -66.10 (95% CI -71.48 to -60.72), p <0.001, ANCOVA
Placebo Q2W vs Evolocumab 105 mg Q2W: LS Mean Treatment Difference: -60.24 (95% CI -65.61 to -54.88), p <0.001, ANCOVA
Placebo Q2W vs Evolocumab 70 mg Q2W: LS Mean Treatment Difference: -41.82 (95% CI -47.18 to -36.45), p <0.001, ANCOVA

Population analysed: Full analysis set; missing ultracentrifugation LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Q2W	4 of 78 (5.1%)	15 of 78 (19.2%)	Not reported
Placebo Q4W	0 of 77 (0%)	17 of 77 (22.1%)	Not reported
Evolocumab 70 mg Q2W	0 of 79 (0%)	20 of 79 (25.3%)	Not reported
Evolocumab 105 mg Q2W	1 of 79 (1.3%)	28 of 79 (35.4%)	Not reported
Evolocumab 140 mg Q2W	4 of 78 (5.1%)	27 of 78 (34.6%)	Not reported
Evolocumab 280 mg Q4W	2 of 79 (2.5%)	21 of 79 (26.6%)	Not reported
Evolocumab 350 mg Q4W	2 of 79 (2.5%)	23 of 79 (29.1%)	Not reported
Evolocumab 420 mg Q4W	2 of 80 (2.5%)	30 of 80 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23141813Giugliano RP, Desai NR, Kohli P, Rogers WJ, Somaratne R, Huang F, Liu T, Mohanavelu S, Hoffman EB, McDonald ST, Abrahamsen TE, Wasserman SM, Scott R, Sabatine MS; LAPLACE-TIMI 57 Investigators. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study. Lancet. 2012 Dec 8;380(9858):2007-17. doi: 10.1016/S0140-6736(12)61770-X. Epub 2012 Nov 6.
Background: PubMed 22714699Kohli P, Desai NR, Giugliano RP, Kim JB, Somaratne R, Huang F, Knusel B, McDonald S, Abrahamsen T, Wasserman SM, Scott R, Sabatine MS. Design and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2012;35(7):385-91. doi: 10.1002/clc.22014. Epub 2012 Jun 19.
Derived from this study: PubMed 23884353Desai NR, Kohli P, Giugliano RP, O'Donoghue ML, Somaratne R, Zhou J, Hoffman EB, Huang F, Rogers WJ, Wasserman SM, Scott R, Sabatine MS. AMG145, a monoclonal antibody against proprotein convertase subtilisin kexin type 9, significantly reduces lipoprotein(a) in hypercholesterolemic patients receiving statin therapy: an analysis from the LDL-C Assessment with Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition Combined with Statin Therapy (LAPLACE)-Thrombolysis in Myocardial Infarction (TIMI) 57 trial. Circulation. 2013 Aug 27;128(9):962-9. doi: 10.1161/CIRCULATIONAHA.113.001969. Epub 2013 Jul 24.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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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

100 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Evolocumab in people with Hyperlipidemia, run by Amgen at 100 sites in 5 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 4 inclusion and 5 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Canada, Czechia, Hungary, Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 1 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?

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 (time frame: Baseline and Week 12). 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 NCT01380730, which also lists 3 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 15 Nov 2022.