720
Participants
Start Date
August 31, 2012
Primary Completion Date
May 31, 2014
Study Completion Date
July 31, 2015
Alirocumab
1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
Placebo (for alirocumab)
1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
Ezetimibe
One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
Placebo (for ezetimibe)
One capsule once daily orally at approximately the same time of the day with or without food.
Lipid Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
Investigational Site Number 348908, Budapest
Investigational Site Number 710918, Middelburg
Investigational Site Number 348901, Budapest
Investigational Site Number 348903, Budapest
Investigational Site Number 710917, Alberton
Investigational Site Number 208901, København S
Investigational Site Number 208914, Glostrup Municipality
Investigational Site Number 208907, Hvidovre
Investigational Site Number 208911, Herlev
Investigational Site Number 208905, Hellerup
Investigational Site Number 208908, Roskilde
Investigational Site Number 348905, Debrecen
Investigational Site Number 208906, Køge
Investigational Site Number 208913, Esbjerg
Investigational Site Number 710915, Somerset West
Investigational Site Number 710905, Cape Town
Investigational Site Number 710904, Cape Town
Investigational Site Number 348906, Székesfehérvár
Investigational Site Number 208903, Silkeborg
Investigational Site Number 710909, Bloemfontein
Investigational Site Number 710914, Bloemfontein
Investigational Site Number 840974, New Windsor
Investigational Site Number 376907, Safed
Investigational Site Number 840940, Oxon Hill
Investigational Site Number 250906, Dijon
Investigational Site Number 840984, Richmond
Investigational Site Number 840931, Norfolk
Investigational Site Number 840985, Winston-Salem
Investigational Site Number 840938, Lexington
Investigational Site Number 840976, Smithfield
Investigational Site Number 840955, Greenville
Investigational Site Number 840913, Charleston
Investigational Site Number 840992, Summerville
Investigational Site Number 840912, Greer
Investigational Site Number 250905, Nîmes
Investigational Site Number 840961, Port Orange
Investigational Site Number 840935, Jacksonville
Investigational Site Number 840981, Oveido
Investigational Site Number 840903, Miami
Investigational Site Number 840962, Boynton Beach
Investigational Site Number 840302, Clearwater
Investigational Site Number 840987, Bradenton
Investigational Site Number 840303, Sarasota
Investigational Site Number 250907, Montpellier
Investigational Site Number 840943, Ocala
Investigational Site Number 840980, Birmingham
Investigational Site Number 840944, Nashville
Investigational Site Number 840932, Bristol
Investigational Site Number 840906, Marion
Investigational Site Number 840997, Marion
Investigational Site Number 840964, Perrysburg
Investigational Site Number 250903, Nantes
Investigational Site Number 840970, Lyndhust
Investigational Site Number 376903, Kfar Saba
Investigational Site Number 840963, Cincinnati
Investigational Site Number 840902, Evansville
Investigational Site Number 376908, Holon
Investigational Site Number 840946, Butte
Investigational Site Number 840998, St Louis
Investigational Site Number 840917, Kansas City
Investigational Site Number 376901, Tel Aviv
Investigational Site Number 840960, Topeka
Investigational Site Number 840914, Lincoln
Investigational Site Number 376904, Rehovot
Investigational Site Number 840994, Fort Worth
Investigational Site Number 840973, Houston
Investigational Site Number 840939, Houston
Investigational Site Number 840971, Tomball
Investigational Site Number 840945, Sugar Land
Investigational Site Number 376906, Ofakim
Investigational Site Number 840995, Meridian
Investigational Site Number 840982, Orem
Investigational Site Number 840918, Phoenix
Investigational Site Number 840949, Albuquerque
Investigational Site Number 804902, Uzhhorod
Investigational Site Number 840979, Los Angeles
Investigational Site Number 840301, Beverly Hills
Investigational Site Number 840930, Thousand Oaks
Investigational Site Number 840933, Chino
Investigational Site Number 840921, Vista
Investigational Site Number 840952, Palm Springs
Investigational Site Number 840959, Anaheim
Investigational Site Number 840991, Lincoln
Investigational Site Number 840928, Renton
Investigational Site Number 840990, Spokane
Investigational Site Number 643927, Moscow
Investigational Site Number 643928, Moscow
Investigational Site Number 643931, Moscow
Investigational Site Number 643924, Moscow
Investigational Site Number 643932, Moscow
Investigational Site Number 643908, Moscow
Investigational Site Number 643904, Moscow
Investigational Site Number 643925, Saint Petersburg
Investigational Site Number 643922, Saint Petersburg
Investigational Site Number 643914, Saint Petersburg
Investigational Site Number 643921, Ryazan
Investigational Site Number 643929, Saratov
Investigational Site Number 643911, Orenburg
Investigational Site Number 643903, Kemerovo
Investigational Site Number 643906, Barnaul
Investigational Site Number 840925, Tucson
Investigational Site Number 840920, Miami
Investigational Site Number 840986, St. Petersburg
Investigational Site Number 840988, St. Petersburg
Investigational Site Number 376902, Petah Tikva
Investigational Site Number 840966, Fall River
Investigational Site Number 124902, Brampton
Investigational Site Number 124914, Mirabel
Investigational Site Number 124903, Montreal
Investigational Site Number 124918, Toronto
Investigational Site Number 710913, Pretoria
Investigational Site Number 410908, Anyang-si
Investigational Site Number 410920, Busan
Investigational Site Number 410926, Daegu
Investigational Site Number 410923, Gwangju
Investigational Site Number 410909, Seoul
Investigational Site Number 410922, Seoul
Investigational Site Number 410921, Seoul
Investigational Site Number 410905, Seoul
Investigational Site Number 410901, Seoul
Investigational Site Number 410914, Seoul
Investigational Site Number 410924, Seoul
Investigational Site Number 410915, Suwon
Investigational Site Number 410913, Uijeongbu-si
Investigational Site Number 410927, Wŏnju
Investigational Site Number 804905, Kiev
Lead Sponsor
Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY