Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Hypercholesterolemia
Interventions
DRUG

Alirocumab

One subcutaneous (SC) injection in the abdomen only.

DRUG

Placebo (for alirocumab)

One SC injection in the abdomen only.

DRUG

Atorvastatin

Over-encapsulated tablet orally once daily in the evening with dinner.

DRUG

Placebo (for atorvastatin)

One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with dinner.

Trial Locations (20)

14609

Investigational Site Number 840606, Rochester

23227

Investigational Site Number 840621, Richmond

32223

Investigational Site Number 840611, Jacksonville

33138

Investigational Site Number 840612, Miami

Investigational Site Number 840614, Miami

33166

Investigational Site Number 840603, Doral

33458

Investigational Site Number 840618, Jupiter

33609

Investigational Site Number 840607, St. Petersburg

45219

Investigational Site Number 840615, Cincinnati

Investigational Site Number 840617, Cincinnati

53575

Investigational Site Number 840613, Oregon

60610

Investigational Site Number 840605, Chicago

Investigational Site Number 840619, Chicago

85206

Investigational Site Number 840616, Mesa

85710

Investigational Site Number 840601, Tucson

90057

Investigational Site Number 840610, Los Angeles

92660

Investigational Site Number 840608, Newport Beach

97404

Investigational Site Number 840602, Eugene

98502

Investigational Site Number 840609, Olympia

08817

Investigational Site Number 840604, Edison

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY