NCT01709513 - Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) | Biotech Hunter

Enrollment

314

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2017

Conditions

Hypercholesterolemia

Interventions

DRUG

Atorvastatin

Atorvastatin over-encapsulated tablets.

DRUG

Ezetimibe

Ezetimibe over-encapsulated tablet.

DRUG

Alirocumab

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

DRUG

Placebo

Placebo for alirocumab, ezitimibe and atorvastatin.

Trial Locations (70)

Unknown

Anaheim

Beverly Hills

Mission Viejo

Newport Beach

Northridge

Thousand Oaks

Hartford

Boynton Beach

Jacksonville

Lakeland

Pembroke Pines

Sarasota

Tampa

Trinity

Addison

Chicago

Indianapolis

Kansas City

Auburn

Boston

Minneapolis

Rochester

St Louis

Clifton

New York

Poughkeepsie

Durham

Cincinnati

Marion

Danville

Philadelphia

Port Matilda

Scranton

Wilkes-Barre

Summerville

Kingsport

Nashville

Dallas

Fort Worth

Salt Lake City

Richmond

Feldkirch

Graz

Innsbruck

Chicoutimi

Montreal (2 Locations)

Sainte-Foy

Bron

Dijon

Lille

Paris

Saint-Herblain

Vénissieux

Holon

Jerusalem

Ofakim

Safed

Tel Litwinsky

Cinisello Balsamo

Napoli

Palermo

Roma

Oslo (2 Locations)

Burton-on-Trent

Chesterfield

Isle of White

Londonderry/N. Ireland

Peterborough

Salford

Stevenage