NCT02023879 - Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) | Biotech Hunter

Enrollment

233

Participants

Timeline

Start Date

December 16, 2013

Primary Completion Date

October 27, 2014

Study Completion Date

June 30, 2017

Conditions

Hypercholesterolemia

Interventions

DRUG

Alirocumab

Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).

DRUG

Placebo (for Alirocumab)

Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).

DRUG

Non-statin LMT

Ezetimibe or Fenofibrate at stable dose as background therapy.

OTHER

Diet Alone

Stable cholesterol-lowering diet as background therapy.

Trial Locations (43)

1023

Investigational Site Number 554702, Auckland

2060

Investigational Site Number 056702, Antwerp

2600

Investigational Site Number 208701, Glostrup Municipality

2650

Investigational Site Number 208704, Hvidovre

3000

Investigational Site Number 056701, Leuven

4102

Investigational Site Number 036701, Woolloongabba

4600

Investigational Site Number 208705, Køge

5035

Investigational Site Number 036703, Ashford

6000

Investigational Site Number 036702, Perth

6700

Investigational Site Number 208702, Esbjerg

7100

Investigational Site Number 056703, Haine-Saint-Paul

8011

Investigational Site Number 554701, Christchurch

8200

Investigational Site Number 208703, Aarhus

14004

Investigational Site Number 724702, Córdoba

15006

Investigational Site Number 724703, A Coruña

15706

Investigational Site Number 724706, Santiago de Compostela

18012

Investigational Site Number 724705, Granada

27710

Investigational Site Number 840707, Durham

29485

Investigational Site Number 840702, Summerville

32216

Investigational Site Number 840708, Jacksonville

33462

Investigational Site Number 840704, Atlantis

34239

Investigational Site Number 840701, Sarasota

50009

Investigational Site Number 724701, Zaragoza

63131

Investigational Site Number 840705, St Louis

90211

Investigational Site Number 840703, Beverly Hills

02720

Investigational Site Number 840706, Fall River

G7H 7P2

Investigational Site Number 124703, Chicoutimi

G1V 4M6

Investigational Site Number 124701, Québec

J1H 1Z1

Investigational Site Number 124704, Sherbrooke

M9V 4B4

Investigational Site Number 124706, Toronto

V5Z 1M9

Investigational Site Number 124702, Vancouver

V8T 5G4

Investigational Site Number 124705, Victoria

1105 AZ

Investigational Site Number 528701, Amsterdam

1782 GZ

Investigational Site Number 528708, Den Helder

7909 AA

Investigational Site Number 528702, Hoogeveen

1625 HV

Investigational Site Number 528703, Hoorn

3045 PM

Investigational Site Number 528706, Rotterdam

8601 ZK

Investigational Site Number 528709, Sneek

3584 CX

Investigational Site Number 528704, Utrecht

5912 BL

Investigational Site Number 528707, Venlo

08025

Investigational Site Number 724707, Barcelona

08035

Investigational Site Number 724710, Barcelona

08970

Investigational Site Number 724709, Sant Joan Despí