NCT01644175 - Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I) | Biotech Hunter

Enrollment

316

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions

Hypercholesterolemia

Interventions

DRUG

Placebo (for alirocumab)

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).

DRUG

Alirocumab

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).

DRUG

Lipid-Modifying Therapy (LMT)

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Trial Locations (76)

3801

Investigational Site Number 840817, Newington

12553

Investigational Site Number 840853, New Windsor

14609

Investigational Site Number 840822, Rochester

15206

Investigational Site Number 840825, Pittsburgh

19146

Investigational Site Number 840869, Philadelphia

19335

Investigational Site Number 840803, Downington

20110

Investigational Site Number 840804, Manassas

23507

Investigational Site Number 840882, Norfolk

24290

Investigational Site Number 840810, Weber City

27103

Investigational Site Number 840502, Winston-Salem

Investigational Site Number 840852, Winston-Salem

29407

Investigational Site Number 840885, Charleston

29464

Investigational Site Number 840827, Mt. Pleasant

29621

Investigational Site Number 840872, Anderson

29651

Investigational Site Number 840813, Greer

31904

Investigational Site Number 840850, Columbus

32127

Investigational Site Number 840881, Port Orange

32765

Investigational Site Number 840811, Oviedo

33134

Investigational Site Number 840866, Coral Gables

33143

Investigational Site Number 840805, Miami

33432

Investigational Site Number 840867, Boca Raton

33472

Investigational Site Number 840884, Boynton Beach

33761

Investigational Site Number 840836, Clearwater

35209

Investigational Site Number 840857, Birmingham

36109

Investigational Site Number 840876, Montgomery

36693

Investigational Site Number 840891, Mobile

39150

Investigational Site Number 840837, Port Gibson

42003

Investigational Site Number 840823, Paducah

43231

Investigational Site Number 840831, Columbus

44094

Investigational Site Number 840809, Willoughby Hills

45219

Investigational Site Number 840846, Cincinnati

45245

Investigational Site Number 840899, Cincinnati

45429

Investigational Site Number 840860, Kettering

46260

Investigational Site Number 840896, Indianapolis

46360

Investigational Site Number 840894, Michigan City

46545

Investigational Site Number 840838, Mishawaka

48034

Investigational Site Number 840832, Southfield

49015

Investigational Site Number 840890, Battle Creek

55435

Investigational Site Number 840839, Edina

55455

Investigational Site Number 840888, Minneapolis

60201

Investigational Site Number 840898, Evanston

60611

Investigational Site Number 840842, Chicago

61550

Investigational Site Number 840847, Morton

65109

Investigational Site Number 840814, Jefferson City

70119

Investigational Site Number 840802, New Orleans

70535

Investigational Site Number 840858, Eunice

72401

Investigational Site Number 840826, Jonesboro

73069

Investigational Site Number 840818, Norman

77070

Investigational Site Number 840877, Houston

77072

Investigational Site Number 840841, Houston

77375

Investigational Site Number 840889, Tomball

78224

Investigational Site Number 840830, San Antonio

78229

Investigational Site Number 840854, San Antonio

78258

Investigational Site Number 840883, San Antonio

78404

Investigational Site Number 840868, Corpus Christi

84010

Investigational Site Number 840878, Bountiful

84058

Investigational Site Number 840819, Orem

84102

Investigational Site Number 840863, Salt Lake City

85306

Investigational Site Number 840865, Glendale

90057

Investigational Site Number 840851, Los Angeles

90505

Investigational Site Number 840862, Torrance

91356

Investigational Site Number 840886, Tarzana

91505

Investigational Site Number 840870, Burbank

92083

Investigational Site Number 840893, Vista

95032

Investigational Site Number 840845, Los Gatos

95116

Investigational Site Number 840801, San Jose

95823

Investigational Site Number 840844, Sacramento

97404

Investigational Site Number 840812, Eugene

33308-4311

Investigational Site Number 840895, Fort Lauderdale

Unknown

Investigational Site Number 840820, Hialeah

Investigational Site Number 840816, West Palm Beach

Investigational Site Number 840840, Eagle

Investigational Site Number 840833, Sparks

Investigational Site Number 840824, Cary

Investigational Site Number 840880, Smithfield

01952

Investigational Site Number 840855, Salisbury