LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
NCT ID: NCT01380730
Last Updated: 2022-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
631 participants
INTERVENTIONAL
2011-07-01
2012-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 105 mg Q2W
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 350 mg Q4W
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Interventions
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Evolocumab
Administered by subcutaneous injection
Placebo to Evolocumab
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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The TIMI Study Group
OTHER
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
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Malvern, Arkansas, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Newport Beach, California, United States
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Roseville, California, United States
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Westlake Village, California, United States
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Colorado Springs, Colorado, United States
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Littleton, Colorado, United States
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Daytona Beach, Florida, United States
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Green Cove Springs, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Port Charlotte, Florida, United States
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Peoria, Illinois, United States
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Hammond, Indiana, United States
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Indianapolis, Indiana, United States
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Valparaiso, Indiana, United States
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Iowa City, Iowa, United States
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Lexington, Kentucky, United States
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Auburn, Maine, United States
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Bangor, Maine, United States
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Portland, Maine, United States
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Kalamazoo, Michigan, United States
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Marquette, Michigan, United States
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Ypsilanti, Michigan, United States
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Tupelo, Mississippi, United States
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Great Falls, Montana, United States
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Voorhees Township, New Jersey, United States
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Cortlandt Manor, New York, United States
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Williamsville, New York, United States
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Smithfield, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Mansfield, Ohio, United States
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Marion, Ohio, United States
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Sandusky, Ohio, United States
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Camp Hill, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
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York, Pennsylvania, United States
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Florence, South Carolina, United States
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Spartanburg, South Carolina, United States
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Rapid City, South Dakota, United States
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Jackson, Tennessee, United States
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Jackson, Tennessee, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Burnaby, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Cambridge, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Oshawa, Ontario, Canada
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Sarnia, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Woodstock, Ontario, Canada
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Gatineau, Quebec, Canada
Research Site
Lachine, Quebec, Canada
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Longueuil, Quebec, Canada
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Pointe-Claire, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
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Slaný, , Czechia
Research Site
Svitavy, , Czechia
Research Site
Ústí nad Orlicí, , Czechia
Research Site
Znojmo, , Czechia
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Dunaújváros, , Hungary
Research Site
Eger, , Hungary
Research Site
Gyula, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Komárom, , Hungary
Research Site
Mosonmagyaróvár, , Hungary
Research Site
Szolnok, , Hungary
Research Site
Zalaegerszeg, , Hungary
Countries
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References
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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.
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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20101155
Identifier Type: -
Identifier Source: org_study_id
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