Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

PHASE3CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

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

Ezetimibe

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

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

Placebo (for Ezetimibe)

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

Trial Locations (8)

2060

Investigational Site Number 056601, Antwerp

23227

Investigational Site Number 840602, Richmond

45219

Investigational Site Number 840601, Cincinnati

66212

Investigational Site Number 840603, Overland Park

00290

Investigational Site Number 246601, Helsinki

9711 SG

Investigational Site Number 528602, Groningen

3021 HC

Investigational Site Number 528601, Rotterdam

6883 ES

Investigational Site Number 528603, Velp

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT01644474 - Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia | Biotech Hunter | Biotech Hunter