Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

PHASE3CompletedINTERVENTIONAL
Enrollment

998

Participants

Timeline

Start Date

June 23, 2015

Primary Completion Date

April 12, 2019

Study Completion Date

April 12, 2019

Conditions
Hypercholesterolemia
Interventions
DRUG

ALIROCUMAB SAR236553 (REGN727)

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

placebo (for injection training only)

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

ezetimibe

Pharmaceutical form:capsule Route of administration: oral

DRUG

atorvastatin

Pharmaceutical form:tablet Route of administration: oral

DRUG

rosuvastatin

Pharmaceutical form:tablet Route of administration: oral

DRUG

simvastatin

Pharmaceutical form:tablet Route of administration: oral

Trial Locations (153)

1030

Investigational Site Number 040003, Vienna

1090

Investigational Site Number 040002, Vienna

Investigational Site Number 056010, Brussels

1125

Investigational Site Number 348001, Budapest

1130

Investigational Site Number 040004, Vienna

1160

Investigational Site Number 040007, Vienna

Investigational Site Number 040010, Vienna

1200

Investigational Site Number 056003, Brussels

2000

Investigational Site Number 705001, Maribor

2020

Investigational Site Number 056018, Antwerp

2650

Investigational Site Number 056007, Edegem

3000

Investigational Site Number 056004, Leuven

3550

Investigational Site Number 724011, Alicante

3600

Investigational Site Number 056019, Genk

3900

Investigational Site Number 056011, Overpelt

4000

Investigational Site Number 056014, Liège

Investigational Site Number 208002, Roskilde

4010

Investigational Site Number 040005, Linz

4021

Investigational Site Number 040006, Linz

4032

Investigational Site Number 348002, Debrecen

4153

Investigational Site Number 756004, Reinach

4600

Investigational Site Number 756002, Olten

5404

Investigational Site Number 756005, Baden

6000

Investigational Site Number 056006, Charleroi

6020

Investigational Site Number 040008, Innsbruck

6700

Investigational Site Number 056008, Arlon

Investigational Site Number 208001, Esbjerg

6725

Investigational Site Number 348003, Szeged

7100

Investigational Site Number 056002, Haine-Saint-Paul

Investigational Site Number 056009, La Louvière

8000

Investigational Site Number 056013, Bruges

8032

Investigational Site Number 756001, Zurich

8500

Investigational Site Number 056015, Kortrijk

8800

Investigational Site Number 056016, Roeselare

9000

Investigational Site Number 056001, Ghent

Investigational Site Number 056017, Ghent

Investigational Site Number 208003, Aalborg

9007

Investigational Site Number 756003, Sankt Gallen

9300

Investigational Site Number 056005, Aalst

11522

Investigational Site Number 300003, Ampelokipoi

12559

Investigational Site Number 276001, Berlin

12808

Investigational Site Number 203001, Prague

13385

Investigational Site Number 250028, Marseille

Investigational Site Number 250048, Marseille

14000

Investigational Site Number 250015, Caen

14004

Investigational Site Number 724003, Córdoba

15706

Investigational Site Number 724002, Santiago de Compostela

20014

Investigational Site Number 724012, Donostia / San Sebastian

Investigational Site Number 724014, Donostia / San Sebastian

20520

Investigational Site Number 246003, Turku

21000

Investigational Site Number 250002, Dijon

Investigational Site Number 250040, Dijon

28007

Investigational Site Number 724004, Madrid

28034

Investigational Site Number 724008, Madrid

28046

Investigational Site Number 724010, Madrid

28630

Investigational Site Number 250032, Coudray

29010

Investigational Site Number 724005, Málaga

29610

Investigational Site Number 250049, Brest

30029

Investigational Site Number 250039, Nîmes

31059

Investigational Site Number 250025, Toulouse

31076

Investigational Site Number 250046, Toulouse

33075

Investigational Site Number 250045, Bordeaux

33604

Investigational Site Number 250051, Pessac

34295

Investigational Site Number 250024, Montpellier

35016

Investigational Site Number 724007, Las Palmas de Gran Canaria

37000

Investigational Site Number 250007, Tours

38028

Investigational Site Number 250012, Grenoble

38043

Investigational Site Number 250038, Grenoble

39120

Investigational Site Number 276003, Magdeburg

44093

Investigational Site Number 250006, Nantes

44277

Investigational Site Number 250022, Nantes

45500

Investigational Site Number 300002, Ioannina

46010

Investigational Site Number 724006, Valencia

46014

Investigational Site Number 724016, Valencia

47011

Investigational Site Number 724015, Valladolid

48960

Investigational Site Number 724017, Galdakao

50005

Investigational Site Number 203002, Hradec Králové

51092

Investigational Site Number 250010, Reims

59000

Investigational Site Number 250042, Lille

63003

Investigational Site Number 250047, Clermont-Ferrand

64100

Investigational Site Number 250021, Bayonne

65691

Investigational Site Number 203004, Brno

68601

Investigational Site Number 203005, Uherské Hradiště

69009

Investigational Site Number 250057, Lyon

69200

Investigational Site Number 250019, Vénissieux

69677

Investigational Site Number 250054, Bron

75014

Investigational Site Number 250014, Paris

Investigational Site Number 250041, Paris

75018

Investigational Site Number 250026, Paris

75181

Investigational Site Number 250044, Paris

75475

Investigational Site Number 250001, Paris

76000

Investigational Site Number 250018, Rouen

78157

Investigational Site Number 250035, Le Chesnay

78300

Investigational Site Number 246001, Varkaus

80054

Investigational Site Number 250027, Amiens

81108

Investigational Site Number 703003, Bratislava

83101

Investigational Site Number 703002, Bratislava

84000

Investigational Site Number 250016, Avignon

86021

Investigational Site Number 250011, Poitiers

Investigational Site Number 250031, Poitiers

87000

Investigational Site Number 250037, Limoges

89011

Investigational Site Number 250034, Auxerre

91100

Investigational Site Number 250013, Corbeil-Essonnes

93009

Investigational Site Number 250030, Bobigny

94160

Investigational Site Number 250023, Saint-Mandé

300298

Investigational Site Number 642-001, Timișoara

700661

Investigational Site Number 642-002, Iași

Unknown

Investigational Site Number 040001, Graz

Investigational Site Number 124028, Trois-Rivières

Investigational Site Number 250033, Jossigny

Investigational Site Number 250036, Lens

Investigational Site Number 250004, Lille

Investigational Site Number 250008, Rennes

Investigational Site Number 300001, Kallithea

Investigational Site Number 348004, Pécs

T2E7C5

Investigational Site Number 124018, Calgary

N1R6V6

Investigational Site Number 124015, Cambridge

G7H7K9

Investigational Site Number 124002, Chicoutimi

V3K3P4

Investigational Site Number 124027, Coquitlam

T6G2B7

Investigational Site Number 124025, Edmonton

B3H1V7

Investigational Site Number 124017, Halifax

L8L 2X2

Investigational Site Number 124013, Hamilton

N6A 4L6

Investigational Site Number 124008, London

V2X5Z6

Investigational Site Number 124026, Maple Ridge

H2W1R7

Investigational Site Number 124020, Montreal

H4A3J1

Investigational Site Number 124022, Montreal

A1N1W7

Investigational Site Number 124032, Mount Pearl

K1Y4W7

Investigational Site Number 124005, Ottawa

K9J0B2

Investigational Site Number 124024, Peterborough

G1V4W2

Investigational Site Number 124003, Québec

J6E6J2

Investigational Site Number 124019, Saint-Charles-Borromée

N7T 4X3

Investigational Site Number 124007, Sarnia

J1H 5N4

Investigational Site Number 124001, Sherbrooke

K7A4W8

Investigational Site Number 124030, Smiths Falls

M4N3M5

Investigational Site Number 124023, Toronto

M5B1W8

Investigational Site Number 124014, Toronto

V5Y3W2

Investigational Site Number 124011, Vancouver

V8T5G4

Investigational Site Number 124012, Victoria

R2H2A6

Investigational Site Number 124031, Winnipeg

N4S5P5

Investigational Site Number 124009, Woodstock

06001

Investigational Site Number 250017, Nice

03201

Investigational Site Number 250050, Vichy

80-952

Investigational Site Number 616005, Gdansk

30-082

Investigational Site Number 616003, Krakow

90-549

Investigational Site Number 616001, Lodz

10-045

Investigational Site Number 616004, Olsztyn

04-628

Investigational Site Number 616002, Warsaw

011461

Investigational Site Number 642-003, Bucharest

04011

Investigational Site Number 703001, Košice

03010

Investigational Site Number 724009, Alicante

03203

Investigational Site Number 724019, Elche

03700

Investigational Site Number 724020, Inca

08907

Investigational Site Number 724001, L'Hospitalet de Llobregat

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY