LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 (LAPLACE-2)

November 4, 2022 updated by: Amgen

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prior to the first randomization, participants entered a screening period to determine eligibility. During screening, all participants received subcutaneous placebo corresponding to the once monthly dose volume. Participants who completed the screening period and met eligibility criteria were randomized to 1 of 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg) for a 4 week lipid stabilization period based on statin therapy at the time of study entry (no statin use vs non-intensive statin use vs intensive statin use).

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.

Study Type

Interventional

Enrollment (Actual)

2067

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2022
        • Research Site
    • South Australia
      • Ashford, South Australia, Australia, 5035
        • Research Site
      • Fullarton, South Australia, Australia, 5063
        • Research Site
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Research Site
      • Heidelberg Heights, Victoria, Australia, 3081
        • Research Site
      • Richmond, Victoria, Australia, 3121
        • Research Site
  • Belgium
      • Blankenberge, Belgium, 8370
        • Research Site
      • Chênée, Belgium, 4032
        • Research Site
      • Hasselt, Belgium, 3500
        • Research Site
      • Oostende, Belgium, 8400
        • Research Site
      • Tremelo, Belgium, 3120
        • Research Site
      • Vilvoorde, Belgium, 1800
        • Research Site
  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 1T4
        • Research Site
      • Kelowna, British Columbia, Canada, V1Y 1V6
        • Research Site
      • Kelowna, British Columbia, Canada, V1Y 1E4
        • Research Site
      • Surrey, British Columbia, Canada, V3V 1N1
        • Research Site
    • Newfoundland and Labrador
      • Saint John’s, Newfoundland and Labrador, Canada, A1A 3R5
        • Research Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Research Site
      • Hamilton, Ontario, Canada, L8L 2X2
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
      • Oshawa, Ontario, Canada, L1J 2K1
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Scarborough, Ontario, Canada, M1P 2T7
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
      • Toronto, Ontario, Canada, M8V 3X8
        • Research Site
      • Woodstock, Ontario, Canada, N4S 5P5
        • Research Site
    • Quebec
      • Brossard, Quebec, Canada, J4X 1S4
        • Research Site
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Research Site
      • Lachine, Quebec, Canada, H8S 2E4
        • Research Site
      • Longueuil, Quebec, Canada, J4N 0C9
        • Research Site
      • Montreal, Quebec, Canada, H4N 2W2
        • Research Site
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
  • Czechia
      • Brno, Czechia, 602 00
        • Research Site
      • Brno, Czechia, 603 00
        • Research Site
      • Kladno, Czechia, 272 01
        • Research Site
      • Litomerice, Czechia, 412 01
        • Research Site
      • Moravske Budejovice, Czechia, 676 02
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Pardubice, Czechia, 530 02
        • Research Site
      • Praha 2, Czechia, 120 00
        • Research Site
      • Praha 3, Czechia, 130 00
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Slany, Czechia, 274 01
        • Research Site
      • Svitavy, Czechia, 568 25
        • Research Site
      • Usti nad Orlici, Czechia, 562 18
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • France
      • Brest Cedex 2, France, 29200
        • Research Site
      • Caen Cedex 9, France, 14033
        • Research Site
      • Dijon, France, 21034
        • Research Site
      • Le Creusot, France, 71200
        • Research Site
      • Montpellier cedex 05, France, 34295
        • Research Site
      • Nantes Cedex 1, France, 44093
        • Research Site
      • Paris, France, 75013
        • Research Site
      • Paris cedex 12, France, 75571
        • Research Site
      • Poitiers, France, 86000
        • Research Site
      • Strasbourg, France, 67091
        • Research Site
  • Germany
      • Bad Krozingen, Germany, 79189
        • Research Site
      • Berlin, Germany, 10367
        • Research Site
      • Berlin, Germany, 10787
        • Research Site
      • Berlin (Hellersdorf), Germany, 12627
        • Research Site
      • Freiburg, Germany, 79106
        • Research Site
      • Heidelberg, Germany, 69120
        • Research Site
      • Homburg, Germany, 66421
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Magdeburg, Germany, 39104
        • Research Site
      • Messkirch, Germany, 88605
        • Research Site
      • Witten, Germany, 58455
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • New Territories, Hong Kong
        • Research Site
  • Hungary
      • Baja, Hungary, 6500
        • Research Site
      • Berettyoujfalu, Hungary, 4100
        • Research Site
      • Dunaujvaros, Hungary, 2400
        • Research Site
      • Eger, Hungary, 3300
        • Research Site
      • Gyongyos, Hungary, 3200
        • Research Site
      • Hodmezovasarhely, Hungary, 6800
        • Research Site
      • Jaszbereny, Hungary, 5100
        • Research Site
      • Komarom, Hungary, 2921
        • Research Site
      • Marcali, Hungary, 8700
        • Research Site
      • Mosonmagyarovar, Hungary, 9200
        • Research Site
      • Pecs, Hungary, 7624
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Research Site
      • Cagliari, Italy, 09134
        • Research Site
      • Chieti, Italy, 66100
        • Research Site
      • Ferrara, Italy, 44124
        • Research Site
      • Milano, Italy, 20162
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Perugia, Italy, 06129
        • Research Site
      • Pisa, Italy, 56124
        • Research Site
      • Trieste, Italy, 34149
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Research Site
      • Seoul, Korea, Republic of, 120-752
        • Research Site
      • Seoul, Korea, Republic of, 138-736
        • Research Site
      • Suwon, Korea, Republic of, 443-721
        • Research Site
      • Suwon-si, Korea, Republic of, 443-380
        • Research Site
  • Mexico
      • Durango, Mexico, 34270
        • Research Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 03800
        • Research Site
      • Mexico, Distrito Federal, Mexico, 14000
        • Research Site
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37520
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Research Site
      • Guadalajara, Jalisco, Mexico, 44100
        • Research Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Research Site
    • San Luis PotosÃ-
      • San Luis Potosi, San Luis PotosÃ-, Mexico, 78240
        • Research Site
    • Tamaulipas
      • Tampico, Tamaulipas, Mexico, 89000
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Research Site
      • Amsterdam, Netherlands, 1066 EC
        • Research Site
      • Den Helder, Netherlands, 1782 GZ
        • Research Site
      • Groningen, Netherlands, 9728 NT
        • Research Site
      • Hoogeveen, Netherlands, 7909 AA
        • Research Site
      • Nieuwegein, Netherlands, 3435 CM
        • Research Site
      • Nijmegen, Netherlands, 6525 GA
        • Research Site
      • Rotterdam, Netherlands, 3045 PM
        • Research Site
      • Waalwijk, Netherlands, 5141 BM
        • Research Site
      • Zwijndrecht, Netherlands, 3331 LZ
        • Research Site
  • Russian Federation
      • Barnaul, Russian Federation, 656055
        • Research Site
      • Kemerovo, Russian Federation, 650002
        • Research Site
      • Moscow, Russian Federation, 121552
        • Research Site
      • Moscow, Russian Federation, 127299
        • Research Site
      • Moscow, Russian Federation, 121002
        • Research Site
      • Novosibirsk, Russian Federation, 630047
        • Research Site
      • Saint Petersburg, Russian Federation, 197341
        • Research Site
      • Saint Petersburg, Russian Federation, 192242
        • Research Site
      • Saint Petersburg, Russian Federation, 197022
        • Research Site
      • Saint-Petersburg, Russian Federation, 194156
        • Research Site
      • Saratov, Russian Federation, 410054
        • Research Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Research Site
      • Cape Town, South Africa, 7405
        • Research Site
    • Gauteng
      • Alberton, Gauteng, South Africa, 1449
        • Research Site
      • Johannesburg, Gauteng, South Africa, 2196
        • Research Site
      • Lyttelton, Gauteng, South Africa, 0140
        • Research Site
      • Pretoria, Gauteng, South Africa, 0184
        • Research Site
    • Western Cape
      • Kuils River, Western Cape, South Africa, 7580
        • Research Site
      • Somerset West, Western Cape, South Africa, 7130
        • Research Site
  • Spain
      • Madrid, Spain, 28007
        • Research Site
      • Madrid, Spain, 28029
        • Research Site
    • AndalucÃ-a
      • Almeria, AndalucÃ-a, Spain, 04001
        • Research Site
      • AlmerÃ-a, AndalucÃ-a, Spain, 04001
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
        • Research Site
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
      • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Research Site
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Research Site
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Lund, Sweden, 222 21
        • Research Site
      • Lund, Sweden, 222 22
        • Research Site
      • Stockholm, Sweden, 171 45
        • Research Site
      • Uddevalla, Sweden, 451 50
        • Research Site
      • Ã-rebro, Sweden, 701 46
        • Research Site
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Research Site
      • Geneva 14, Switzerland, 1211
        • Research Site
      • Lausanne, Switzerland, 1011
        • Research Site
      • Muensterlingen, Switzerland, 8596
        • Research Site
      • St. Gallen, Switzerland, 9007
        • Research Site
      • Zurich, Switzerland, 8063
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Research Site
      • Kaohsiung, Taiwan, 83301
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
        • Research Site
      • Blackpool, United Kingdom, FY3 7EN
        • Research Site
      • Cardiff, United Kingdom, CF14 5GJ
        • Research Site
      • Chesterfield, United Kingdom, S40 4TF
        • Research Site
      • Chorley, United Kingdom, PR7 7NA
        • Research Site
      • Doncaster, United Kingdom, DN9 1EP
        • Research Site
      • Glasgow, United Kingdom, G20 0SP
        • Research Site
      • Glasgow, United Kingdom, G45 9AW
        • Research Site
      • Harrow, United Kingdom, HA3 7LT
        • Research Site
      • Liverpool, United Kingdom, L7 8XP
        • Research Site
      • Liverpool, United Kingdom, L22 0LG
        • Research Site
      • Manchester, United Kingdom, M15 6SX
        • Research Site
      • Manchester, United Kingdom, M13 9WL
        • Research Site
      • Reading, United Kingdom, RG2 0TG
        • Research Site
      • Reading, United Kingdom, RG2 0FT
        • Research Site
      • Scunthorpe, United Kingdom, DN15 7BH
        • Research Site
      • Wakefield, United Kingdom, WF1 4DG
        • Research Site
      • Whitby, United Kingdom, YO21 1SD
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Research Site
      • Tucson, Arizona, United States, 85712
        • Research Site
      • Tucson, Arizona, United States, 85710
        • Research Site
    • California
      • Carmichael, California, United States, 95608
        • Research Site
      • Encino, California, United States, 91436
        • Research Site
      • Long Beach, California, United States, 90822
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • San Diego, California, United States, 92123
        • Research Site
      • Santa Ana, California, United States, 92705
        • Research Site
      • Santa Rosa, California, United States, 95405
        • Research Site
      • Thousand Oaks, California, United States, 91360
        • Research Site
      • Torrance, California, United States, 90509
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
      • Westlake Village, California, United States, 91361
        • Research Site
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Research Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • Jacksonville, Florida, United States, 32223
        • Research Site
      • Melbourne, Florida, United States, 32901
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Port Charlotte, Florida, United States, 33952
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
      • Atlanta, Georgia, United States, 30342
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Research Site
    • Indiana
      • Hammond, Indiana, United States, 46320
        • Research Site
      • Indianapolis, Indiana, United States, 46237
        • Research Site
      • Valparaiso, Indiana, United States, 46383
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Research Site
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
      • Bangor, Maine, United States, 04401
        • Research Site
      • Portland, Maine, United States, 04101
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Montana
      • Billings, Montana, United States, 59102
        • Research Site
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Research Site
    • New York
      • Manlius, New York, United States, 13104
        • Research Site
      • Rochester, New York, United States, 14609
        • Research Site
      • Syracuse, New York, United States, 13210
        • Research Site
      • Williamsville, New York, United States, 14221
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Cadiz, Ohio, United States, 43907
        • Research Site
      • Canton, Ohio, United States, 44708
        • Research Site
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45227
        • Research Site
      • Dayton, Ohio, United States, 45414
        • Research Site
      • Mansfield, Ohio, United States, 44906
        • Research Site
      • Marion, Ohio, United States, 43302
        • Research Site
      • Sandusky, Ohio, United States, 44870
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15216
        • Research Site
      • York, Pennsylvania, United States, 17405
        • Research Site
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Research Site
      • Jackson, Tennessee, United States, 38301
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Suffolk, Virginia, United States, 23435
        • Research Site
      • Winchester, Virginia, United States, 22601
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female ≥ 18 to ≤ 80 years of age
  • 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:

  • Statin intolerance
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Placebo to Ezetimibe
Administered orally once a day
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Placebo to Ezetimibe
Administered orally once a day
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Active Comparator: 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.
Drug: Ezetimibe
Administered orally once a day
Other Names:
  • Zetia
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Active Comparator: 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.
Drug: Ezetimibe
Administered orally once a day
Other Names:
  • Zetia
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Placebo to Ezetimibe
Administered orally once a day
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Experimental: 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
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Placebo to Ezetimibe
Administered orally once a day
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Placebo to Ezetimibe
Administered orally once a day
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Placebo to Ezetimibe
Administered orally once a day
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Active Comparator: 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.
Drug: Ezetimibe
Administered orally once a day
Other Names:
  • Zetia
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Active Comparator: 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.
Drug: Ezetimibe
Administered orally once a day
Other Names:
  • Zetia
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Placebo to Ezetimibe
Administered orally once a day
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Placebo to Ezetimibe
Administered orally once a day
Drug: Atorvastatin
Administered orally once a day
Other Names:
  • Lipitor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Rosuvastatin
Administered orally once a day
Other Names:
  • Crestor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Rosuvastatin
Administered orally once a day
Other Names:
  • Crestor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Rosuvastatin
Administered orally once a day
Other Names:
  • Crestor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Rosuvastatin
Administered orally once a day
Other Names:
  • Crestor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Rosuvastatin
Administered orally once a day
Other Names:
  • Crestor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Rosuvastatin
Administered orally once a day
Other Names:
  • Crestor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Rosuvastatin
Administered orally once a day
Other Names:
  • Crestor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Rosuvastatin
Administered orally once a day
Other Names:
  • Crestor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Simvastatin
Administered orally once a day
Other Names:
  • Zocor
Placebo Comparator: 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.
Drug: Placebo to Evolocumab
Administered by subcutaneous injection
Drug: Simvastatin
Administered orally once a day
Other Names:
  • Zocor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Simvastatin
Administered orally once a day
Other Names:
  • Zocor
Experimental: 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.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Simvastatin
Administered orally once a day
Other Names:
  • Zocor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Time Frame: Weeks 10 and 12
Weeks 10 and 12
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Time Frame: Week 12
Week 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in HDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2013

Primary Completion (Actual)

November 12, 2013

Study Completion (Actual)

December 4, 2013

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110115
  • 2012-001363-70 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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