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

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Hypercholesterolemia
Interventions
DRUG

Alirocumab

Two SC injections in the abdomen only

DRUG

Placebo (for alirocumab)

"Two subcutaneous (SC) injections in the abdomen only~Route of administration: subcutaneous injection (1 mL) in the abdomen"

DRUG

Atorvastatin

"Orally once daily at a stable dose of 5 to 20 mg as background therapy~Route of administration: oral administration in the evening"

Trial Locations (4)

Unknown

Investigational Site Number 392002, Koganeishi

Investigational Site Number 392001, Shinjuku-Ku

Investigational Site Number 392003, Suita-Shi

Investigational Site Number 392004, Suita-Shi

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT01812707 - Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan | Biotech Hunter | Biotech Hunter