Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

PHASE3CompletedINTERVENTIONAL
Enrollment

720

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

July 31, 2015

Conditions
Hypercholesterolemia
Interventions
DRUG

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.

DRUG

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.

DRUG

Ezetimibe

One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.

DRUG

Placebo (for ezetimibe)

One capsule once daily orally at approximately the same time of the day with or without food.

DRUG

Lipid Modifying Therapy (LMT)

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.

Trial Locations (126)

1036

Investigational Site Number 348908, Budapest

1055

Investigational Site Number 710918, Middelburg

1134

Investigational Site Number 348901, Budapest

Investigational Site Number 348903, Budapest

1450

Investigational Site Number 710917, Alberton

2300

Investigational Site Number 208901, København S

2600

Investigational Site Number 208914, Glostrup Municipality

2650

Investigational Site Number 208907, Hvidovre

2730

Investigational Site Number 208911, Herlev

2900

Investigational Site Number 208905, Hellerup

4000

Investigational Site Number 208908, Roskilde

4032

Investigational Site Number 348905, Debrecen

4600

Investigational Site Number 208906, Køge

6700

Investigational Site Number 208913, Esbjerg

7130

Investigational Site Number 710915, Somerset West

7500

Investigational Site Number 710905, Cape Town

7925

Investigational Site Number 710904, Cape Town

8000

Investigational Site Number 348906, Székesfehérvár

8600

Investigational Site Number 208903, Silkeborg

9301

Investigational Site Number 710909, Bloemfontein

Investigational Site Number 710914, Bloemfontein

12553

Investigational Site Number 840974, New Windsor

13100

Investigational Site Number 376907, Safed

20745

Investigational Site Number 840940, Oxon Hill

21079

Investigational Site Number 250906, Dijon

23227

Investigational Site Number 840984, Richmond

23502

Investigational Site Number 840931, Norfolk

27103

Investigational Site Number 840985, Winston-Salem

27292

Investigational Site Number 840938, Lexington

27577

Investigational Site Number 840976, Smithfield

27834

Investigational Site Number 840955, Greenville

29412

Investigational Site Number 840913, Charleston

29485

Investigational Site Number 840992, Summerville

29651

Investigational Site Number 840912, Greer

30900

Investigational Site Number 250905, Nîmes

32127

Investigational Site Number 840961, Port Orange

32223

Investigational Site Number 840935, Jacksonville

32765

Investigational Site Number 840981, Oveido

33126

Investigational Site Number 840903, Miami

33472

Investigational Site Number 840962, Boynton Beach

33756

Investigational Site Number 840302, Clearwater

34203

Investigational Site Number 840987, Bradenton

34239

Investigational Site Number 840303, Sarasota

34295

Investigational Site Number 250907, Montpellier

34471

Investigational Site Number 840943, Ocala

35209

Investigational Site Number 840980, Birmingham

37205

Investigational Site Number 840944, Nashville

37620

Investigational Site Number 840932, Bristol

43302

Investigational Site Number 840906, Marion

Investigational Site Number 840997, Marion

43551

Investigational Site Number 840964, Perrysburg

44093

Investigational Site Number 250903, Nantes

44124

Investigational Site Number 840970, Lyndhust

44281

Investigational Site Number 376903, Kfar Saba

45219

Investigational Site Number 840963, Cincinnati

47714

Investigational Site Number 840902, Evansville

58100

Investigational Site Number 376908, Holon

59701

Investigational Site Number 840946, Butte

63131

Investigational Site Number 840998, St Louis

64114

Investigational Site Number 840917, Kansas City

64239

Investigational Site Number 376901, Tel Aviv

66606

Investigational Site Number 840960, Topeka

68510

Investigational Site Number 840914, Lincoln

76100

Investigational Site Number 376904, Rehovot

76104

Investigational Site Number 840994, Fort Worth

77070

Investigational Site Number 840973, Houston

77074

Investigational Site Number 840939, Houston

77375

Investigational Site Number 840971, Tomball

77479

Investigational Site Number 840945, Sugar Land

80300

Investigational Site Number 376906, Ofakim

83646

Investigational Site Number 840995, Meridian

84058

Investigational Site Number 840982, Orem

85032

Investigational Site Number 840918, Phoenix

87106

Investigational Site Number 840949, Albuquerque

88009

Investigational Site Number 804902, Uzhhorod

90057

Investigational Site Number 840979, Los Angeles

90211

Investigational Site Number 840301, Beverly Hills

91360

Investigational Site Number 840930, Thousand Oaks

91710

Investigational Site Number 840933, Chino

92083

Investigational Site Number 840921, Vista

92262

Investigational Site Number 840952, Palm Springs

92801

Investigational Site Number 840959, Anaheim

95648

Investigational Site Number 840991, Lincoln

98055

Investigational Site Number 840928, Renton

99204

Investigational Site Number 840990, Spokane

111539

Investigational Site Number 643927, Moscow

Investigational Site Number 643928, Moscow

115404

Investigational Site Number 643931, Moscow

119048

Investigational Site Number 643924, Moscow

121374

Investigational Site Number 643932, Moscow

121552

Investigational Site Number 643908, Moscow

129090

Investigational Site Number 643904, Moscow

197110

Investigational Site Number 643925, Saint Petersburg

198205

Investigational Site Number 643922, Saint Petersburg

199106

Investigational Site Number 643914, Saint Petersburg

390026

Investigational Site Number 643921, Ryazan

410028

Investigational Site Number 643929, Saratov

450000

Investigational Site Number 643911, Orenburg

650002

Investigational Site Number 643903, Kemerovo

656055

Investigational Site Number 643906, Barnaul

Unknown

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

02720

Investigational Site Number 840966, Fall River

L6T 3J1

Investigational Site Number 124902, Brampton

J7J 2K8

Investigational Site Number 124914, Mirabel

H1T 3Y7

Investigational Site Number 124903, Montreal

M9V 4B4

Investigational Site Number 124918, Toronto

0002

Investigational Site Number 710913, Pretoria

431-070

Investigational Site Number 410908, Anyang-si

602-715

Investigational Site Number 410920, Busan

700-712

Investigational Site Number 410926, Daegu

501-757

Investigational Site Number 410923, Gwangju

110-744

Investigational Site Number 410909, Seoul

120-752

Investigational Site Number 410922, Seoul

135-710

Investigational Site Number 410921, Seoul

135-720

Investigational Site Number 410905, Seoul

137-701

Investigational Site Number 410901, Seoul

138-736

Investigational Site Number 410914, Seoul

156-707

Investigational Site Number 410924, Seoul

443-721

Investigational Site Number 410915, Suwon

480-717

Investigational Site Number 410913, Uijeongbu-si

220-701

Investigational Site Number 410927, Wŏnju

02091

Investigational Site Number 804905, Kiev

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY