Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

PHASE3CompletedINTERVENTIONAL
Enrollment

305

Participants

Timeline

Start Date

November 30, 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

Rosuvastatin

Rosuvastatin over-encapsulated tablets orally.

DRUG

Ezetimibe

Ezetimibe over-encapsulated tablets orally.

DRUG

Placebo

Placebo for alirocumab and ezetimibe.

Trial Locations (93)

Unknown

Chandler

Tucson

Anaheim

Beverly Hills

Fair Oaks

Newport Beach

Northridge

Sacramento

Walnut Creek

Milford

Atlantis

Bradenton

Clearwater

Fort Lauderdale

Jacksonville

Lakeland

(2 Locations), Miami

Oviedo

Pinellas Park

Port Orange

Sarasota

Tampa

West Palm Beach

Winter Park

Boise

Morton

Evansville

Indianapolis

Newton

Overland Park

Wichita

Lexington

Louisville

Auburn

Bethesda

Edina

Rochester

Olive Branch

Port Gibson

St Louis

Butte

Williamsville

Cincinnati

Marion

Portland

Warwick

Greer

Summerville

Kingsport

Dallas

Fort Worth

Houston

Bountiful

Salt Lake City

Herston

New Lambton Heights

Perth

Sherwood

Woolloongabba

Brampton

Burlington

Etobicoke

London

Newmarket

Thornhill

Toronto

Chicoutimi

Dijon

Lille

Bad Oeynhausen

Berlin

Cologne

Regensburg

Ulm

Chieti

Genova

Napoli

Palermo

(2 Locations), Roma

Baja California

Distrito Federal

(3 Locations), Guadalajara

Monterrey

Zapopan Jalisco

(2 Locations), Barcelona

Madrid

Santiago

Seville

West Bromwich

Chester

Peterborough

Salford

Stevenage

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Regeneron Pharmaceuticals

INDUSTRY