LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
NCT ID: NCT01763866
Last Updated: 2022-11-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2067 participants
INTERVENTIONAL
2013-01-15
2013-12-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
NCT01763827
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
NCT01375764
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
NCT01763905
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
NCT01375777
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
NCT02662569
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After the 4-week lipid-stabilization period, eligible patients taking rosuvastatin or simvastatin during the lipid-stabilization phase were then randomized to 1 of 4 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) or matching placebo (subcutaneous, every 2 weeks), or evolocumab (420 mg, subcutaneous, monthly) or matching placebo (subcutaneous, monthly). Patients taking atorvastatin during the lipid-stabilization phase were then randomized to 1 of 6 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) and placebo (oral, daily), evolocumab (420 mg, subcutaneous, monthly) and placebo (oral, daily), placebo (subcutaneous, every 2 weeks) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily), or placebo (subcutaneous, monthly) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily).
A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria, and undergoing both randomization procedures.
Participants randomized to simvastatin who were taking verapamil or diltiazem prior to randomization received simvastatin 10 mg once daily (QD) while participants who were taking amlodipine, amiodarone or ranolazine prior to randomization received simvastatin 20 mg QD. All other participants randomized to simvastatin received simvastatin 40 mg QD.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once a day for up to 12 weeks.
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Atorvastatin
Administered orally once a day
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Atorvastatin
Administered orally once a day
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks
Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month and placebo tablets once a day for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Atorvastatin
Administered orally once a day
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Atorvastatin
Administered orally once a day
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Rosuvastatin
Administered orally once a day
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Rosuvastatin
Administered orally once a day
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Rosuvastatin
Administered orally once a day
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Rosuvastatin
Administered orally once a day
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Rosuvastatin
Administered orally once a day
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Rosuvastatin
Administered orally once a day
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Rosuvastatin
Administered orally once a day
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Rosuvastatin
Administered orally once a day
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Simvastatin
Administered orally once a day
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Simvastatin
Administered orally once a day
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Simvastatin
Administered orally once a day
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Simvastatin
Administered orally once a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Evolocumab
Administered by subcutaneous injection
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once a day
Atorvastatin
Administered orally once a day
Rosuvastatin
Administered orally once a day
Simvastatin
Administered orally once a day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)
* Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)
* Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria
* New York Heart association (NYHA) III or IV heart failure
* Uncontrolled hypertension
* Uncontrolled cardiac arrhythmia
* Type 1 diabetes, poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Reading, , United Kingdom
Research Site
Reading, , United Kingdom
Research Site
Scunthorpe, , United Kingdom
Research Site
Wakefield, , United Kingdom
Research Site
Whitby, , United Kingdom
Research Site
Chesterfield, , United Kingdom
Research Site
Chorley, , United Kingdom
Research Site
Doncaster, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Harrow, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Birmingham, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Carmichael, California, United States
Research Site
Encino, California, United States
Research Site
Long Beach, California, United States
Research Site
Newport Beach, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Ana, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Thousand Oaks, California, United States
Research Site
Torrance, California, United States
Research Site
Tustin, California, United States
Research Site
Westlake Village, California, United States
Research Site
Littleton, Colorado, United States
Research Site
Daytona Beach, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Port Charlotte, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Boise, Idaho, United States
Research Site
Hammond, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Valparaiso, Indiana, United States
Research Site
Iowa City, Iowa, United States
Research Site
Crestview Hills, Kentucky, United States
Research Site
Monroe, Louisiana, United States
Research Site
Auburn, Maine, United States
Research Site
Bangor, Maine, United States
Research Site
Portland, Maine, United States
Research Site
Baltimore, Maryland, United States
Research Site
Ypsilanti, Michigan, United States
Research Site
Tupelo, Mississippi, United States
Research Site
Billings, Montana, United States
Research Site
Voorhees Township, New Jersey, United States
Research Site
Manlius, New York, United States
Research Site
Rochester, New York, United States
Research Site
Syracuse, New York, United States
Research Site
Williamsville, New York, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cadiz, Ohio, United States
Research Site
Canton, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Mansfield, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Sandusky, Ohio, United States
Research Site
Norman, Oklahoma, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
York, Pennsylvania, United States
Research Site
Florence, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Jackson, Tennessee, United States
Research Site
Jackson, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Suffolk, Virginia, United States
Research Site
Winchester, Virginia, United States
Research Site
Tacoma, Washington, United States
Research Site
Sydney, New South Wales, Australia
Research Site
Ashford, South Australia, Australia
Research Site
Fullarton, South Australia, Australia
Research Site
Fitzroy, Victoria, Australia
Research Site
Heidelberg Heights, Victoria, Australia
Research Site
Richmond, Victoria, Australia
Research Site
Blankenberge, , Belgium
Research Site
Chênée, , Belgium
Research Site
Hasselt, , Belgium
Research Site
Ostend, , Belgium
Research Site
Tremelo, , Belgium
Research Site
Vilvoorde, , Belgium
Research Site
Burnaby, British Columbia, Canada
Research Site
Kelowna, British Columbia, Canada
Research Site
Kelowna, British Columbia, Canada
Research Site
Surrey, British Columbia, Canada
Research Site
Saint John’s, Newfoundland and Labrador, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Sarnia, Ontario, Canada
Research Site
Scarborough Village, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Woodstock, Ontario, Canada
Research Site
Brossard, Quebec, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Lachine, Quebec, Canada
Research Site
Longueuil, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Pointe-Claire, Quebec, Canada
Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
Research Site
Kladno, , Czechia
Research Site
Litoměřice, , Czechia
Research Site
Moravské Budějovice, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Pardubice, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Slaný, , Czechia
Research Site
Svitavy, , Czechia
Research Site
Ústí nad Orlicí, , Czechia
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Brest, , France
Research Site
Caen, , France
Research Site
Dijon, , France
Research Site
Le Creusot, , France
Research Site
Montpellier, , France
Research Site
Nantes, , France
Research Site
Paris, , France
Research Site
Paris, , France
Research Site
Poitiers, , France
Research Site
Strasbourg, , France
Research Site
Bad Krozingen, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
Heidelberg, , Germany
Research Site
Hellersdorf, , Germany
Research Site
Homburg, , Germany
Research Site
Leipzig, , Germany
Research Site
Magdeburg, , Germany
Research Site
Messkirch, , Germany
Research Site
Witten, , Germany
Research Site
Hong Kong, , Hong Kong
Research Site
New Territories, , Hong Kong
Research Site
Baja, , Hungary
Research Site
Berettyóújfalu, , Hungary
Research Site
Dunaújváros, , Hungary
Research Site
Eger, , Hungary
Research Site
Gyöngyös, , Hungary
Research Site
Hódmezővásárhely, , Hungary
Research Site
Jászberény, , Hungary
Research Site
Komárom, , Hungary
Research Site
Marcali, , Hungary
Research Site
Mosonmagyaróvár, , Hungary
Research Site
Pécs, , Hungary
Research Site
Bologna, , Italy
Research Site
Cagliari, , Italy
Research Site
Chieti, , Italy
Research Site
Ferrara, , Italy
Research Site
Milan, , Italy
Research Site
Napoli, , Italy
Research Site
Padua, , Italy
Research Site
Perugia, , Italy
Research Site
Pisa, , Italy
Research Site
Trieste, , Italy
Research Site
León, Guanajuato, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Monterrey, Nuevo León, Mexico
Research Site
San Luis Potosí City, San Luis PotosÃ-, Mexico
Research Site
Tampico, Tamaulipas, Mexico
Research Site
Durango, , Mexico
Research Site
Amsterdam, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Den Helder, , Netherlands
Research Site
Groningen, , Netherlands
Research Site
Hoogeveen, , Netherlands
Research Site
Nieuwegein, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Waalwijk, , Netherlands
Research Site
Zwijndrecht, , Netherlands
Research Site
Barnaul, , Russia
Research Site
Kemerovo, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saratov, , Russia
Research Site
Alberton, Gauteng, South Africa
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Lyttelton, Gauteng, South Africa
Research Site
Pretoria, Gauteng, South Africa
Research Site
Kuils River, Western Cape, South Africa
Research Site
Somerset West, Western Cape, South Africa
Research Site
Bloemfontein, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Suwon, , South Korea
Research Site
AlmerÃ-a, AndalucÃ-a, Spain
Research Site
Almería, AndalucÃ-a, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
L'Hospitalet de Llobregat, Cataluña, Spain
Research Site
Pozuelo de Alarcón, Madrid, Spain
Research Site
Pozuelo de Alarcón, Madrid, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Ã-rebro, , Sweden
Research Site
Göteborg, , Sweden
Research Site
Lund, , Sweden
Research Site
Lund, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Uddevalla, , Sweden
Research Site
Bellinzona, , Switzerland
Research Site
Geneva, , Switzerland
Research Site
Lausanne, , Switzerland
Research Site
Muensterlingen, , Switzerland
Research Site
Sankt Gallen, , Switzerland
Research Site
Zurich, , Switzerland
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Birmingham, , United Kingdom
Research Site
Blackpool, , United Kingdom
Research Site
Cardiff, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Robinson JG, Nedergaard BS, Rogers WJ, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R; LAPLACE-2 Investigators. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA. 2014 May 14;311(18):1870-82. doi: 10.1001/jama.2014.4030.
Robinson JG, Rogers WJ, Nedergaard BS, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R. Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2014 Apr;37(4):195-203. doi: 10.1002/clc.22252. Epub 2014 Jan 30.
Daviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.
Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.
Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.
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.
Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.
Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.
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.
Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.
Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.
May HT, Muhlestein JB, Ma Y, Lopez JAG, Coll B, Nelson J. Effects of Evolocumab on the ApoA1 Remnant Ratio: A Pooled Analysis of Phase 3 Studies. Cardiol Ther. 2019 Jun;8(1):91-102. doi: 10.1007/s40119-019-0133-6. Epub 2019 Mar 9.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-001363-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110115
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.