Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

PHASE3CompletedINTERVENTIONAL
Enrollment

355

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

May 31, 2014

Conditions
Hypercholesterolemia
Interventions
DRUG

Alirocumab

Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.

DRUG

Atorvastatin

Atorvastatin over-encapsulated tablets orally.

DRUG

Ezetimibe

Ezetimibe over-encapsulated tablet orally.

DRUG

Rosuvastatin

Rosuvastatin over-encapsulated tablets orally.

DRUG

Placebo

Placebo for alirocumab and ezetimibe.

Trial Locations (97)

Unknown

Mobile

Chandler

Tucson

Anaheim

Beverly Hills

Lakeland Village

Newport Beach

Northridge

Sacramento

Walnut Creek

Milford

Atlantis

Boca Raton

Clearwater

Jacksonville

Miami (2 Locations)

Oviedo

Pinellas Park

Port Orange

Sarasota

Tampa

West Palm Beach

Boise

Meridian

Chicago

Morton

Indianapolis

Newton

Overland Park

Wichita

Lexington

Louisville

Auburn

Bethesda

Edina

Rochester

Olive Branch

Port Gibson

St Louis

Butte

Las Vegas

Williamsville

Winston-Salem

Cleveland

Oklahoma City

Warwick

Greer

Summerville

Kingsport

Dallas (2 Locations)

Fort Worth

Houston

Bountiful

Marion

Salt Lake City

Renton

Herston QLD

New Lambton Heights

Perth

Sherwood

Woolloongabba

Brampton

Etobicoke

London

Newmarke

Thornhill

Toronto

Chicoutimi

Dijon

Lille

Vénissieux

Bad Oeynhausen

Berlin

Cologne

Munich

Regensburg

Ulm

Chiete

Genova

Napoli

Palermo

Roma (2 Locations)

Distrito Federal

Guadalajara

Guadalajara, Jalisco

Monterrey Nuevo Leon

Tijuana Baja California

Zapopan Jalisco

Barcelona (3 Locations)

Madrid

Sant Joan Despí

Carmarthen

Chester

Peterborough

Salford

Stevenage

West Bromwich, West Midlands

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Regeneron Pharmaceuticals

INDUSTRY