Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Hypercholesterolemia
Interventions
DRUG

Alirocumab

Two SC injections in the abdomen only.

DRUG

Placebo (for alirocumab)

Two subcutaneous (SC) injections in the abdomen only.

DRUG

Atorvastatin

Orally once daily at a stable dose of 10 mg, 20 mg, or 40 mg as background therapy.

Trial Locations (38)

14609

Investigational Site Number 840538, Rochester

23227

Investigational Site Number 840518, Richmond

23502

Investigational Site Number 840517, Norfolk

27612

Investigational Site Number 840508, Raleigh

28677

Investigational Site Number 840522, Statesville

32081

Investigational Site Number 840524, Ponte Vedra

32127

Investigational Site Number 840536, Port Orange

32216

Investigational Site Number 840514, Jacksonville

33026

Investigational Site Number 840520, Pembroke Pines

33108

Investigational Site Number 840504, Aventura

Investigational Site Number 840519, Aventura

33143

Investigational Site Number 840502, Miami

33458

Investigational Site Number 840539, Jupiter

33609

Investigational Site Number 840507, St. Petersburg

37620

Investigational Site Number 840521, Bristol

42431

Investigational Site Number 840532, Madisonville

44124

Investigational Site Number 840510, Lyndhurst

45219

Investigational Site Number 840511, Cincinnati

Investigational Site Number 840526, Cincinnati

46260

Investigational Site Number 840529, Indianapolis

47714

Investigational Site Number 840506, Evansville

60611

Investigational Site Number 840527, Chicago

67203

Investigational Site Number 840515, Wichita

74136

Investigational Site Number 840533, Tulsa

80903

Investigational Site Number 840530, Colorado Springs

84010

Investigational Site Number 840531, Bountiful

85282

Investigational Site Number 840525, Tempe

89123

Investigational Site Number 840512, Las Vegas

90057

Investigational Site Number 840516, Los Angeles

91361

Investigational Site Number 840534, Westlake Village

92262

Investigational Site Number 840523, Palm Springs

92660

Investigational Site Number 840509, Newport Beach

92691

Investigational Site Number 840528, Mission Viejo

97404

Investigational Site Number 840537, Eugene

98502

Investigational Site Number 840513, Olympia

04210

Investigational Site Number 840535, Auburn

02301

Investigational Site Number 840503, Brockton

08817

Investigational Site Number 840505, Edison

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY