Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

PHASE3CompletedINTERVENTIONAL
Enrollment

2,341

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Hypercholesterolemia
Interventions
DRUG

Placebo (for alirocumab)

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

DRUG

Alirocumab

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

DRUG

Lipid-Modifying Therapy (LMT)

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Trial Locations (320)

181

Investigational Site Number 710002, Pretoria

1036

Investigational Site Number 348007, Budapest

Investigational Site Number 348009, Budapest

1055

Investigational Site Number 710011, Middelburg

1119

Investigational Site Number 032008, Capital Federal

1135

Investigational Site Number 348008, Budapest

1136

Investigational Site Number 348013, Budapest

1203

Investigational Site Number 100005, Sofia

1233

Investigational Site Number 100012, Sofia

Investigational Site Number 100015, Sofia

1527

Investigational Site Number 100009, Sofia

1606

Investigational Site Number 100001, Sofia

1724

Investigational Site Number 710009, Roodepoort

2020

Investigational Site Number 056005, Antwerp

Investigational Site Number 578004, Skedsmokorset

2193

Investigational Site Number 710006, Parktown

2317

Investigational Site Number 578001, Hamar

2402

Investigational Site Number 578005, Elverum

2900

Investigational Site Number 208004, Hellerup

3600

Investigational Site Number 056004, Genk

4000

Investigational Site Number 100014, Plovdiv

4005

Investigational Site Number 578003, Stavanger

4032

Investigational Site Number 348004, Debrecen

4200

Investigational Site Number 208003, Slagelse

4400

Investigational Site Number 348006, Nyíregyháza

5360

Investigational Site Number 056001, Natoye

5700

Investigational Site Number 208001, Svendborg

5800

Investigational Site Number 100008, Pleven

6000

Investigational Site Number 100013, Stara Zagora

6500

Investigational Site Number 348003, Baja

6850

Investigational Site Number 710007, Worcester

7130

Investigational Site Number 710003, Somerset West

8142

Investigational Site Number 348011, Úrhida

8200

Investigational Site Number 208005, Aarhus

8800

Investigational Site Number 208002, Viborg

Investigational Site Number 348002, Nagykanizsa

9010

Investigational Site Number 100007, Varna

9050

Investigational Site Number 620006, Funchal / Madeira

9230

Investigational Site Number 056002, Wetteren

9400

Investigational Site Number 348001, Sopron

10002

Investigational Site Number 804005, Zhytomyr

10708

Investigational Site Number 840097, Bronxville

11215

Investigational Site Number 840129, Brooklyn

12601

Investigational Site Number 840160, Poughkeepsie

12627

Investigational Site Number 276007, Berlin

13125

Investigational Site Number 276005, Berlin

13158

Investigational Site Number 276014, Berlin

14004

Investigational Site Number 724006, Córdoba

14186

Investigational Site Number 752004, Stockholm

15006

Investigational Site Number 203007, Prague

15009

Investigational Site Number 840170, Beaver

15800

Investigational Site Number 203006, Prague

16100

Investigational Site Number 376004, Nazareth

16635

Investigational Site Number 840004, Duncansville

17011

Investigational Site Number 840180, Camp Hill

17740

Investigational Site Number 840046, Jersey Shore

18012

Investigational Site Number 724003, Granada

18101

Investigational Site Number 376002, Afula

18508

Investigational Site Number 840177, Scranton

19055

Investigational Site Number 276006, Schwerin

19460

Investigational Site Number 840155, Phoenixville

19610

Investigational Site Number 840202, Wyomissing

20092

Investigational Site Number 380002, Cinisello Balsamo

20138

Investigational Site Number 380009, Milan

21000

Investigational Site Number 250004, Dijon

22500

Investigational Site Number 484002, Tijuana

23320

Investigational Site Number 840204, Chesapeake

27000

Investigational Site Number 484009, Torreón

27270

Investigational Site Number 250003, Broglie

27408

Investigational Site Number 840083, Greensboro

27609

Investigational Site Number 840104, Raleigh

28040

Investigational Site Number 724002, Madrid

28211

Investigational Site Number 840023, Charlotte

28803

Investigational Site Number 840217, Asheville

29010

Investigational Site Number 724007, Málaga

29485

Investigational Site Number 840073, Charleston

29615

Investigational Site Number 840087, Greenville

29681

Investigational Site Number 840074, Simpsonville

29944

Investigational Site Number 840105, Varnville

30041

Investigational Site Number 840117, Cumming

30076

Investigational Site Number 840110, Roswell

30159

Investigational Site Number 276019, Hanover

31029

Investigational Site Number 380008, Vittorio Veneto

31405

Investigational Site Number 840026, Savannah

32003

Investigational Site Number 840167, Fleming Island

32081

Investigational Site Number 840168, Ponte Vedra

32117

Investigational Site Number 840002, Daytona Beach

Investigational Site Number 840166, Daytona Beach

32169

Investigational Site Number 840122, New Smyrna Beach

32174

Investigational Site Number 840108, Ormond Beach

32204

Investigational Site Number 840153, Jacksonville

32205

Investigational Site Number 840181, Jacksonville

32216

Investigational Site Number 840152, Jacksonville

32746

Investigational Site Number 840154, Lake Mary

33026

Investigational Site Number 840006, Pembroke Pines

33176

Investigational Site Number 840221, Miami

33308

Investigational Site Number 840090, Fort Lauderdale

33309

Investigational Site Number 840018, Fort Lauderdale

33401

Investigational Site Number 840036, West Palm Beach

33462

Investigational Site Number 840150, Atlantis

33511

Investigational Site Number 840041, Brandon

33604

Investigational Site Number 250010, Pessac

33756

Investigational Site Number 840184, Clearwater

Investigational Site Number 840242, Clearwater

33765

Investigational Site Number 840039, Clearwater

33773

Investigational Site Number 840059, Largo

34208

Investigational Site Number 840020, Bradenton

34239

Investigational Site Number 840164, Sarasota

Investigational Site Number 840175, Sarasota

34429

Investigational Site Number 840182, Crystal River

34471

Investigational Site Number 840151, Ocala

34652

Investigational Site Number 840021, New Port Richey

34684

Investigational Site Number 840067, Palm Harbor

35033

Investigational Site Number 250012, Rennes

35801

Investigational Site Number 840159, Huntsville

37917

Investigational Site Number 840190, Knoxville

39104

Investigational Site Number 276012, Magdeburg

39120

Investigational Site Number 276003, Magdeburg

41013

Investigational Site Number 724004, Seville

43201

Investigational Site Number 724005, Reus

43302

Investigational Site Number 840013, Marion

44060

Investigational Site Number 840161, Mentor

44093

Investigational Site Number 250009, Nantes

44300

Investigational Site Number 250001, Nantes

44787

Investigational Site Number 276008, Bochum

45236

Investigational Site Number 840068, Cincinnati

45355

Investigational Site Number 276004, Essen

45406

Investigational Site Number 840007, Dayton

46260

Investigational Site Number 840093, Indianapolis

46930

Investigational Site Number 724008, Quart de Poblet

47714

Investigational Site Number 840027, Evansville

48374

Investigational Site Number 840193, Novi

48604

Investigational Site Number 840162, Saginaw

49006

Investigational Site Number 804003, Dnipropetrovsk

49310

Investigational Site Number 250008, Vihiers

50266

Investigational Site Number 840165, West Des Moines

52242

Investigational Site Number 840222, Iowa City

58013

Investigational Site Number 804012, Chernivtsi

58100

Investigational Site Number 376003, Holon

Investigational Site Number 376005, Holon

58455

Investigational Site Number 276015, Witten

59037

Investigational Site Number 250006, Lille

59690

Investigational Site Number 250005, Vieux-Condé

60596

Investigational Site Number 276010, Frankfurt A.M.

61002

Investigational Site Number 804014, Kharkiv

63117

Investigational Site Number 840033, St Louis

63131

Investigational Site Number 840113, St Louis

66013

Investigational Site Number 380006, Chieti

67100

Investigational Site Number 246001, Kokkola

67203

Investigational Site Number 840040, Wichita

67205

Investigational Site Number 840061, Wichita

67207

Investigational Site Number 840032, Wichita

Investigational Site Number 840084, Wichita

69677

Investigational Site Number 250014, Bron

70146

Investigational Site Number 752001, Örebro

70210

Investigational Site Number 246003, Kuopio

74136

Investigational Site Number 840005, Tulsa

75023

Investigational Site Number 840053, Plano

75216

Investigational Site Number 840092, Dallas

75226

Investigational Site Number 840212, Dallas

75651

Investigational Site Number 250002, Paris

75701

Investigational Site Number 840241, Tyler

76104

Investigational Site Number 840058, Fort Worth

Investigational Site Number 840149, Fort Worth

76117

Investigational Site Number 840070, Fort Worth

77024

Investigational Site Number 840038, Houston

77074

Investigational Site Number 840047, Houston

77479

Investigational Site Number 840072, Sugar Land

78200

Investigational Site Number 484001, San Luis Potosí City

79530

Investigational Site Number 752002, Rättvik

80100

Investigational Site Number 246002, Joensuu

80131

Investigational Site Number 380007, Napoli

80401

Investigational Site Number 840077, Golden

80906

Investigational Site Number 840086, Colorado Springs

81423

Investigational Site Number 616003, Gdynia

83114

Investigational Site Number 804002, Donetsk

83150

Investigational Site Number 250007, Bandol

83646

Investigational Site Number 840075, Meridian

84107

Investigational Site Number 840031, Salt Lake City

85282

Investigational Site Number 840052, Tempe

Investigational Site Number 840065, Tempe

Investigational Site Number 840079, Tempe

Investigational Site Number 840094, Tempe

85295

Investigational Site Number 840028, Gilbert

85635

Investigational Site Number 840035, Sierra Vista

86077

Investigational Site Number 380005, Pozzilli

86825

Investigational Site Number 276001, Bad Wörishofen

89052

Investigational Site Number 840095, Henderson

Investigational Site Number 840096, Henderson

90127

Investigational Site Number 380001, Palermo

90210

Investigational Site Number 840209, Beverly Hills

90211

Investigational Site Number 840194, Beverly Hills

90807

Investigational Site Number 840076, Long Beach

91020

Investigational Site Number 484003, Xalapa

91105

Investigational Site Number 840214, Pasadena

93720

Investigational Site Number 840207, Fresno

95405

Investigational Site Number 840163, Santa Rosa

95648

Investigational Site Number 840101, Lincoln

95842

Investigational Site Number 840045, Sacramento

99204

Investigational Site Number 840120, Spokane

119415

Investigational Site Number 643012, Moscow

125284

Investigational Site Number 643008, Moscow

150002

Investigational Site Number 643004, Yaroslavl

196084

Investigational Site Number 643006, Saint Petersburg

Investigational Site Number 643009, Saint Petersburg

300358

Investigational Site Number 642001, Timișoara

430031

Investigational Site Number 642005, Baia Mare

500283

Investigational Site Number 642002, Brasov

540099

Investigational Site Number 642004, Târgu Mureş

614097

Investigational Site Number 643014, Perm

4790869

Investigational Site Number 152004, Temuco

5311092

Investigational Site Number 152007, Osorno

7980378

Investigational Site Number 152008, Santiago

8053095

Investigational Site Number 152006, Santiago

85741-3565

Investigational Site Number 840103, Tucson

06610

Investigational Site Number 840224, Bridgeport

06437

Investigational Site Number 840134, Guilford

06102

Investigational Site Number 840246, Hartford

06905

Investigational Site Number 840055, Stamford

Investigational Site Number 840091, Stamford

Unknown

Investigational Site Number 840001, St. Petersburg

Investigational Site Number 840003, St. Petersburg

Investigational Site Number 170004, Barranquilla

Investigational Site Number 170005, Barranquilla

Investigational Site Number 170008, Barranquilla

Investigational Site Number 170001, Manizales

Investigational Site Number 170003, Medellín

Investigational Site Number 380010, Zingonia-Osio Sotto

Investigational Site Number 484008, Not Provided

Investigational Site Number 578002, Oslo

Investigational Site Number 643005, Barnaul

Investigational Site Number 710005, Witbank

Investigational Site Number 804013, Kyiv

66160-7321

Investigational Site Number 840200, Kansas City

04005

Investigational Site Number 840244, Biddeford

01702

Investigational Site Number 840158, Framingham

08817

Investigational Site Number 840022, Edison

08844

Investigational Site Number 840011, Hillsborough

08611

Investigational Site Number 840049, Trenton

53209-0996

Investigational Site Number 840111, Milwaukee

C1425DES

Investigational Site Number 032006, Buenos Aires

C1440AAD

Investigational Site Number 032010, Caba

B7540GHD

Investigational Site Number 032001, Coronel Suárez

H3500CDM

Investigational Site Number 032004, Resistencia

B2800DGH

Investigational Site Number 032007, Zárate

N1R 6V6

Investigational Site Number 124013, Cambridge

V3K 3P4

Investigational Site Number 124027, Coquitlam

K6A 1A1

Investigational Site Number 124001, Hawkesbury

N5W 6A2

Investigational Site Number 124002, London

J7J 2K8

Investigational Site Number 124009, Mirabel

H1T 3Y7

Investigational Site Number 124018, Montreal

K1K 4L2

Investigational Site Number 124007, Ottawa

G1V 4M6

Investigational Site Number 124011, Québec

N7T 4X3

Investigational Site Number 124008, Sarnia

A1A 3R5

Investigational Site Number 124005, St. John's

J6V 1S8

Investigational Site Number 124022, Terrebonne

V5Z 1M9

Investigational Site Number 124003, Vancouver

V8T 5G4

Investigational Site Number 124006, Victoria

N4S 5P5

Investigational Site Number 124015, Woodstock

128 08

Investigational Site Number 203004, Prague

01600

Investigational Site Number 246004, Vantaa

01067

Investigational Site Number 276009, Dresden

02826

Investigational Site Number 276011, Görlitz

04103

Investigational Site Number 276013, Leipzig

03300

Investigational Site Number 484010, Df

06090

Investigational Site Number 484004, México

1091 AC

Investigational Site Number 528013, Amsterdam

1105 AZ

Investigational Site Number 528001, Amsterdam

4811 SW

Investigational Site Number 528004, Breda

5616GB

Investigational Site Number 528005, Eindhoven

9711 SG

Investigational Site Number 528007, Groningen

7909 AA

Investigational Site Number 528011, Hoogeveen

1625 HV

Investigational Site Number 528002, Hoorn

2352 RA

Investigational Site Number 528008, Leiderdorp

3021 HC

Investigational Site Number 528009, Rotterdam

6883 ES

Investigational Site Number 528006, Velp

5912 BL

Investigational Site Number 528012, Venlo

2724 EK

Investigational Site Number 528010, Zoetermeer

81-384

Investigational Site Number 616008, Gdynia

88-140

Investigational Site Number 616001, Gniewkowo

40-748

Investigational Site Number 616010, Katowice

31-315

Investigational Site Number 616018, Krakow

97-300

Investigational Site Number 616004, Piotrkow Trybunalski

24-100

Investigational Site Number 616013, Puławy

02-777

Investigational Site Number 616009, Warsaw

50-088

Investigational Site Number 616007, Wroclaw

1169-024

Investigational Site Number 620002, Lisbon

1549-008

Investigational Site Number 620001, Lisbon

4200-319

Investigational Site Number 620005, Porto

0158

Investigational Site Number 710010, Centurion

0184

Investigational Site Number 710008, Meyerspark

0002

Investigational Site Number 710004, Pretoria

0084

Investigational Site Number 710001, Pretoria

08208

Investigational Site Number 724001, Sabadell

111 35

Investigational Site Number 752006, Stockholm

111 57

Investigational Site Number 752003, Stockholm

02091

Investigational Site Number 804016, Kiev

01103

Investigational Site Number 804011, Kyiv

03115

Investigational Site Number 804010, Kyiv

03680

Investigational Site Number 804001, Kyiv

04053

Investigational Site Number 804008, Kyiv

KT15 2BH

Investigational Site Number 826004, Addlestone

B15 2SQ

Investigational Site Number 826009, Birmingham

B18 7QH

Investigational Site Number 826016, Birmingham

FY3 7EN

Investigational Site Number 826021, Blackpool

CB2 OQQ

Investigational Site Number 826023, Cambridge

CF14 5GJ

Investigational Site Number 826012, Cardiff

PO19 4SE

Investigational Site Number 826024, Chichester

PR7 7NA

Investigational Site Number 826006, Chorley

G20 0SP

Investigational Site Number 826010, Glasgow

KA12 0AY

Investigational Site Number 826003, Irvine

L22 0LG

Investigational Site Number 826008, Liverpool

L7 8XP

Investigational Site Number 826005, Liverpool

M13 9WL

Investigational Site Number 826025, Manchester

M15 6SX

Investigational Site Number 826007, Manchester

HA6 2RN

Investigational Site Number 826001, Middlesex

TR19 7HH

Investigational Site Number 826019, Penzance

RG2 7AG

Investigational Site Number 826011, Reading

RM7 0AG

Investigational Site Number 826013, Romford

CB7 5JD

Investigational Site Number 826014, Soham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT01507831 - Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term) | Biotech Hunter | Biotech Hunter