413
Participants
Start Date
March 15, 2016
Primary Completion Date
March 22, 2017
Study Completion Date
May 15, 2017
Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
Statins
Statins at stable dose without other LMT as clinically indicated.
Ezetimibe
Pharmaceutical form: tablet Route of administration: oral
Fenofibrate
Pharmaceutical form: tablet Route of administration: oral
Nicotinic acid
Pharmaceutical form: tablet Route of administration: oral
Omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral
Antihyperglycemic Drug
Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.
Investigational Site Number 756101, Geneva
Investigational Site Number 036101, St Leonards
Investigational Site Number 036104, Merewether
Investigational Site Number 036102, Herston
Investigational Site Number 756103, Reinach
Investigational Site Number 784101, Dubai
Investigational Site Number 756102, Olten
Investigational Site Number 840-181, New York
Investigational Site Number 840-157, New York
Investigational Site Number 380102, Torino
Investigational Site Number 840-178, Albany
Investigational Site Number 276112, Berlin
Investigational Site Number 276109, Berlin
Investigational Site Number 752101, Stockholm
Investigational Site Number 840-151, Rockville
Investigational Site Number 840-171, Richmond
Investigational Site Number 840-126, Chesapeake
Investigational Site Number 276102, Oldenburg in Holstein
Investigational Site Number 380104, Bergamo
Investigational Site Number 840-188, Greensboro
Investigational Site Number 840-131, Morehead City
Investigational Site Number 840-158, Morganton
Investigational Site Number 840-111, Summerville
Investigational Site Number 840-169, Stockbridge
Investigational Site Number 792109, Hatay
Investigational Site Number 840-128, Columbus
Investigational Site Number 840-179, Oviedo
Investigational Site Number 840-107, Boca Raton
Investigational Site Number 840-170, Boynton Beach
Investigational Site Number 246104, Tampere
Investigational Site Number 840-123, Tampa
Investigational Site Number 840-114, Bradenton
Investigational Site Number 840-132, Ocoee
Investigational Site Number 380108, Padua
Investigational Site Number 792104, Izmir
Investigational Site Number 840-147, Chattanooga
Investigational Site Number 840-159, Knoxville
Investigational Site Number 792107, Kayseri
Investigational Site Number 840-137, Bainbridge
Investigational Site Number 752102, Gothenburg
Investigational Site Number 840-183, Paducah
Investigational Site Number 840-104, Columbus
Investigational Site Number 840-105, Marion
Investigational Site Number 840-175, Maumee
Investigational Site Number 276110, Essen
Investigational Site Number 276108, Essen
Investigational Site Number 276111, Goch
Investigational Site Number 380101, Pisa
Investigational Site Number 840-129, Fargo
Investigational Site Number 840-184, Crystal Lake
Investigational Site Number 840-174, Evanston
Investigational Site Number 840-161, Chicago
Investigational Site Number 840-138, Springfield
Investigational Site Number 840-120, St Louis
Investigational Site Number 840-113, Jefferson City
Investigational Site Number 840-190, Metairie
Investigational Site Number 840-163, Little Rock
Investigational Site Number 840-153, Dallas
Investigational Site Number 276107, Karlsruhe
Investigational Site Number 840-143, Houston
Investigational Site Number 840-168, Houston
Investigational Site Number 840-133, Tomball
Investigational Site Number 840-142, Round Rock
Investigational Site Number 380103, Napoli
Investigational Site Number 840-167, Idaho Falls
Investigational Site Number 840-185, Orem
Investigational Site Number 840-150, Salt Lake City
Investigational Site Number 380107, Catanzaro
Investigational Site Number 840-101, Las Vegas
Investigational Site Number 840-140, Las Vegas
Investigational Site Number 380106, Partinico
Investigational Site Number 840-118, Los Angeles
Investigational Site Number 246102, Oulu
Investigational Site Number 246101, Oulu
Investigational Site Number 840-106, Northridge
Investigational Site Number 840-122, Tarzana
Investigational Site Number 840-160, Van Nuys
Investigational Site Number 840-115, La Jolla
Investigational Site Number 840-152, Huntington Beach
Investigational Site Number 840-176, Port Hueneme
Investigational Site Number 840-141, Fresno
Investigational Site Number 276103, Künzing
Investigational Site Number 840-136, Bend
Investigational Site Number 076103, Campinas
Investigational Site Number 840-156, Tustin
Investigational Site Number 840-108, Louisville
Investigational Site Number 076102, São Paulo
Investigational Site Number 376101, Beersheba
Investigational Site Number 376103, Petah Tikva
Investigational Site Number 376104, Petah Tikva
Investigational Site Number 376102, Rehovot
Investigational Site Number 376106, Tel Aviv
Investigational Site Number 414101, Kuwait City
Investigational Site Number 422101, Beirut
Investigational Site Number 422102, Hazmiyeh
Investigational Site Number 792102, Ankara
Investigational Site Number 792108, Çorum
Investigational Site Number 792101, Izmir
Investigational Site Number 792110, Izmir
Investigational Site Number 792103, Samsun
Investigational Site Number 840-148, Omaha
Investigational Site Number 840-187, Murrells Inlet
Investigational Site Number 076104, Fortaleza
Investigational Site Number 076105, São Paulo
Investigational Site Number 076101, São Paulo
Investigational Site Number 076106, São Paulo
Investigational Site Number 276104, Dippoldiswalde
Investigational Site Number 276101, Dresden
Investigational Site Number 380105, Roma
Investigational Site Number 578101, Oslo
Investigational Site Number 578102, Oslo
Investigational Site Number 792105, Adana
Investigational Site Number 792106, Ankara
Investigational Site Number 826104, Exeter
Investigational Site Number 826106, Manchester
Investigational Site Number 826105, Middlesbrough
Investigational Site Number 826103, Stevenage
Investigational Site Number 826101, Torquay
Investigational Site Number 826102, West Bromwich
Lead Sponsor
Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY