Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).
The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85018, United States
Beverly Hills, California 90210, United States
Fullerton, California 92835, United States
Torrance, California 90502, United States
Vista, California 92083, United States
Clearwater, Florida 33756, United States
Sarasota, Florida 34239, United States
Tamarac, Florida 33319, United States
Blackfoot, Idaho 83221, United States
Chicago, Illinois 60631, United States
Evansville, Indiana 47725, United States
Iowa City, Iowa 52242, United States
Marrero, Louisiana 70072, United States
New Orleans, Louisiana 70112, United States
New Orleans, Louisiana 70112, United States
Troy, Michigan 48098, United States
Duluth, Minnesota 55805, United States
Duluth, Minnesota 55805, United States
New Brunswick, New Jersey 08901, United States
North Massapequa, New York 11758-1802, United States
Mooresville, North Carolina 28117, United States
Winston-Salem, North Carolina 27157, United States
Cincinnati, Ohio 45219, United States
Youngstown, Ohio 44501, United States
Doylestown, Pennsylvania 18901, United States
Sellersville, Pennsylvania 18960, United States
Houston, Texas 77030, United States
Richmond, Virginia 23225, United States
Richmond, Virginia 23225, United States
C.a.b.a., Buenos Aires C1119ACN, Argentina
Ciudad Autonoma de B. Aires, Buenos Aires C1280AEB, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1179AAB, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DES, Argentina
C.a.b.a, Buenos Aires F.D. C1023AAB, Argentina
C.a.b.a, C.a.b.a. C1425AGC, Argentina
Godoy Cruz, Mendoza Province M5501ARP, Argentina
Santa Fe, PCIA de Santa FE S3004CVS, Argentina
Rosario, Pcia. de Santa FE S2000CFK, Argentina
Rosario, Santa Fe Province S2000QID, Argentina
Ciudad Autonoma de B. Aires, C1405BUB, Argentina
Ciudad Autonoma de B. Aires, C1428ART, Argentina
Camperdown, New South Wales 2050, Australia
Daws Park, South Australia 5041, Australia
Fortaleza, Ceará 60430-140, Brazil
Salvador, Estado de Bahia 41810-011, Brazil
Indianapolis, Indiana 46214-2985, Brazil
Belo Horizonte, Minas Gerais 30150-240, Brazil
Campina Grande do Sul, Paraná 83430-000, Brazil
Belém, Pará 66073-000, Brazil
Rio de Janeiro, Rio de Janeiro 22271-100, Brazil
Canoas, Rio Grande do Sul 92425-055, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Porto Alegre, Rio Grande do Sul 90110-270, Brazil
Porto Alegre, Rio Grande do Sul 90620-001, Brazil
Porto Alegre, Rio Grande do Sul 90840-440, Brazil
Porto Alegre, Rio Grande do Sul 90840-440, Brazil
Campinas, São Paulo 13010-001, Brazil
São José do Rio Preto, São Paulo 15015210, Brazil
São Paulo, São Paulo 05403-010, Brazil
Minas Gerais, 30150-240, Brazil
São Paulo, 01244-030, Brazil
Cambridge, Ontario N1R 7R1, Canada
Saint-Charles-Borromée, Quebec J6E 6J2, Canada
Saint-Jérôme, Quebec J7Z 5T3, Canada
St-Georges, Beauce, Quebec G5Y 4T8, Canada
Providencia Santiago, Santiago Metropolitan 7500710, Chile
Medellín, Antioquia, Colombia
Barranquila, Atlántico, Colombia
Barranquilla, Atlántico, Colombia
Bogota D.C., Cundinamarca 110911, Colombia
Bogota D.C., Cundinamarca, Colombia
Bogota D.C, Cundinamarca 110221, Colombia
Bogota D.C, Cundinamarca 111211, Colombia
Bogota D.C, Cundinamarca, Colombia
Bogota D.C, Cundinamarca, Colombia
Floridablanca, Santander Department, Colombia
Hradec Králové, 500 05, Czechia
Copenhagen NV, 2400, Denmark
Copenhagen Oe, 2100, Denmark
Helsinki, FI-00290, Finland
Essen, 45359, Germany
Falkensee, 14612, Germany
Greifswald, 17475, Germany
Homburgsaar, 66421, Germany
Lahr, 77933, Germany
Magdeburg, 39120, Germany
Nuremberg, 90402, Germany
Stuhr-Brinkum, 28816, Germany
Budapest, 1125, Hungary
Ahmedabad, Gujarat 380007, India
Meyrin/Geneve, Geneve 1217, Italy
Palermo, PA 90127, Italy
Perugia, PG 06132, Italy
Lecco, Province OF Lecco 23900, Italy
Naples, 80131, Italy
Cd. Juarez, Chihuahua 32472, Mexico
Acapulco de Juárez, Guerrero 39670, Mexico
Acapulco de Juárez, Guerrero 39670, Mexico
Mexico City, Mexico City 11650, Mexico
Mexico City, Mexico City 14000, Mexico
Culiacán, Sinaloa 80020, Mexico
Tampico, Tamaulipas 89000, Mexico
México, 11650, Mexico
Sittard-Geleen, Limburg 6162 BG, Netherlands
Tilburg, 5022 GC, Netherlands
Frimley, Hastings 4120, New Zealand
Christchurch, 8011, New Zealand
Lodz, Iodzkie 92-213, Poland
Grudziądz, Kuyavian-Pomeranian Voivodeship 86-300, Poland
Włocławek, Kuyavian-Pomeranian Voivodeship 87-800, Poland
Krakow, Lesser Poland Voivodeship 31-121, Poland
Krakow, Lesser Poland Voivodeship 31-202, Poland
Krakow, Lesser Poland Voivodeship 31-216, Poland
Krakow, Lesser Poland Voivodeship 31-531, Poland
Myślenice, Lesser Poland Voivodeship 32-400, Poland
Nowy Targ, Lesser Poland Voivodeship 34-400, Poland
Tarnów, Lesser Poland Voivodeship 33-100, Poland
Tarnów, Lesser Poland Voivodeship 33-100, Poland
Jelenia Góra, Lower Silesian Voivodeship 58-506, Poland
Wroclaw, Lower Silesian Voivodeship 51-124, Poland
Katowice, Masovian Voivodeship 40-040, Poland
Płock, Masovian Voivodeship 09-402, Poland
Warsaw, Masovian Voivodeship 02-507, Poland
Warsaw, Masovian Voivodeship 02-507, Poland
Warsaw, Masovian Voivodeship 04-141, Poland
Warsaw, Masovian Voivodeship 04-628, Poland
Warsaw, Masovian Voivodeship 04-730, Poland
Brzozów, Podkarpackie Voivodeship 36-200, Poland
Krosno, Podkarpackie Voivodeship 38400, Poland
Bialystok, Podlaskie Voivodeship 15-351, Poland
Gdansk, Pomeranian Voivodeship 80-542, Poland
Gdansk, Pomeranian Voivodeship 80-546, Poland
Gdynia, Pomeranian Voivodeship 81-423, Poland
Starogard Gdański, Pomeranian Voivodeship 83-200, Poland
Bytom, Silesian Voivodeship 41-902, Poland
Ruda Śląska, Silesian Voivodeship 41-709, Poland
Elblag, Warmian-Masurian Voivodeship 82-300, Poland
Krakow, 31-501, Poland
Myślenice, 32-400, Poland
Piotrkow Trybunalski, Łódź Voivodeship 97-300, Poland
Anasco, 00610, Puerto Rico
Timișoara, Judet Timis 300456, Romania
Târgu Mureş, Mureș County 540143, Romania
Ploieşti, Prahova 100163, Romania
Brasov, 500283, Romania
Brăila, 810249, Romania
Bucharest, 020045, Romania
Cluj-Napoca, 400006, Romania
Satu Mare, 440055, Romania
Tg. Mures, 540124, Romania
Timișoara, 300125, Romania
Krasnodar, Krasnodarskiy Kray 350086, Russia
Lubertsy, Moscow Oblast 140006, Russia
Troitsk, Moscow Oblast 142190, Russia
Saint Petersburg, Sankt-Peterburg 197022, Russia
Saint Petersburg, Sestroretsk 197706, Russia
Kazan', Tatarstan Republic 420033, Russia
Chelyabinsk, 454047, Russia
Kaluga, 428007, Russia
Kazan', 420012, Russia
Kemerovo, 650000, Russia
Kemerovo, 650000, Russia
Kemerovo, 650002, Russia
Kemerovo, 650099, Russia
Kirov, 610014, Russia
Kursk, 305035, Russia
Moscow, 111539, Russia
Moscow, 121359, Russia
Moscow, 121552, Russia
Moscow, 127644, Russia
Moscow, 129090, Russia
Novosibirsk, 630089, Russia
Novosibirsk, 630102, Russia
Penza, 440026, Russia
Rostov-on-Don, 344022, Russia
Rostov-on-Don, 344068, Russia
Saint Petersburg, 192148, Russia
Saint Petersburg, 193312, Russia
Saint Petersburg, 196247, Russia
Saint Petersburg, 197022, Russia
Saint Petersburg, 197022, Russia
Saint Petersburg, 197110, Russia
Saint Petersburg, 197341, Russia
Saint Petersburg, 198205, Russia
Saint-Petersberg, 191186, Russia
Samara, 443070, Russia
Tyumen, 625000, Russia
Tyumen, 625026, Russia
Yaroslavl, 150003, Russia
Yaroslavl, 150010, Russia
Yaroslavl, 150023, Russia
Bratislava, Bratislava Region 826 06, Slovakia
Bratislava, 811 08, Slovakia
Bratislava, 81369, Slovakia
Bratislava, 826 06, Slovakia
Bratislava, 841 08, Slovakia
Liptovský Mikuláš, 031 23, Slovakia
Merebank, Durban, KwaZulu-Natal 4052, South Africa
Gauteng, 1619, South Africa
Wŏnju, Gangwon-do 26426, South Korea
Uijeongbu-si, Gyeonggi-do 11765, South Korea
Seoul, 156-707, South Korea
Santiago de Compostela, A Coruna 15706, Spain
el Prat de Llobregat, Barcelona/cataluna 08820, Spain
Salt, Girona, Girona 17190, Spain
Ferrol, 15401, Spain
Mölndal, 431 80, Sweden
Bangkoknoi, Bangkok 10700, Thailand
Muang, Changwat Khon Kaen 40002, Thailand
Hat Yai, Changwat Songkhla 90110, Thailand
Bangkok, 10400, Thailand
Bangkok, 10400, Thailand
Afyonkarahisar, 03200, Turkey (Türkiye)
Ankara, 06520, Turkey (Türkiye)
Gaziantep, 27310, Turkey (Türkiye)
Kocaeli, 41380, Turkey (Türkiye)
Rize, 53020, Turkey (Türkiye)
Peterborough, Cambridgeshire PE3 9GZ, United Kingdom
Manchester, Greater Manchester M15 6SX, United Kingdom
Welwyn Garden City, Hertfordshire AL7 4HQ, United Kingdom
Layton, Blackpool, Lancashire FY3 7EN, United Kingdom
Portadown, Northern Ireland BT63 5QQ, United Kingdom
Hexham, Northumberland NE46 1QJ, United Kingdom
Manchester, South Yorkshire M13 9WL, United Kingdom
Birmingham, B9 5SS, United Kingdom
East Sussex, TN39 4SP, United Kingdom
East Sussex, TN40 1JJ, United Kingdom
Glosgow, G51 4TF, United Kingdom
London, W12 OHS, United Kingdom