Open Label Study of Long Term Safety Evaluation of Alirocumab

PHASE3CompletedINTERVENTIONAL
Enrollment

986

Participants

Timeline

Start Date

December 17, 2013

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Hypercholesterolemia
Interventions
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 (177)

1130

Investigational Site Number 040301, Vienna

1233

Investigational Site Number 100302, Sofia

1527

Investigational Site Number 100301, Sofia

1724

Investigational Site Number 710315, Roodepoort

2193

Investigational Site Number 710312, Parktown

4000

Investigational Site Number 208303, Roskilde

5360

Investigational Site Number 056301, Natoye

5700

Investigational Site Number 208304, Svendborg

6500

Investigational Site Number 348301, Baja

6700

Investigational Site Number 208302, Esbjerg

7130

Investigational Site Number 710310, Somerset West

7500

Investigational Site Number 710304, Parow

7530

Investigational Site Number 710311, Bellville

7700

Investigational Site Number 710306, Cape Town

7925

Investigational Site Number 710302, Cape Town

8036

Investigational Site Number 040302, Graz

8092

Investigational Site Number 578301, Bodø

8200

Investigational Site Number 208306, Aarhus

8511

Investigational Site Number 040303, Sankt Stefan

9000

Investigational Site Number 208301, Aalborg

9301

Investigational Site Number 710307, Bloemfontein

10032

Investigational Site Number 840316, New York

10117

Investigational Site Number 276302, Berlin

12601

Investigational Site Number 840324, Poughkeepsie

12808

Investigational Site Number 203305, Prague

13110

Investigational Site Number 376303, Safed

14004

Investigational Site Number 724306, Córdoba

14021

Investigational Site Number 203301, Prague

14186

Investigational Site Number 752304, Stockholm

15001

Investigational Site Number 724303, A Coruña

15006

Investigational Site Number 203306, Praha 5 - Motol

15009

Investigational Site Number 840352, Beaver

18012

Investigational Site Number 724312, Granada

18503

Investigational Site Number 840342, Scranton

19104

Investigational Site Number 840308, Philadelphia

20037

Investigational Site Number 840328, Washington D.C.

20138

Investigational Site Number 380304, Milan

21000

Investigational Site Number 250303, Dijon

23320

Investigational Site Number 840354, Chesapeake

27609

Investigational Site Number 840348, Raleigh

27710

Investigational Site Number 840320, Durham

28007

Investigational Site Number 724301, Madrid

28029

Investigational Site Number 724309, Madrid

28040

Investigational Site Number 724305, Madrid

Investigational Site Number 724311, Madrid

28204

Investigational Site Number 840303, Charlotte

29010

Investigational Site Number 724314, Málaga

29485

Investigational Site Number 840304, Summerville

32216

Investigational Site Number 840327, Jacksonville

33174

Investigational Site Number 840309, Miami

33462

Investigational Site Number 840344, Atlantis

33604

Investigational Site Number 250305, Pessac

33756

Investigational Site Number 840353, Clearwater

34239

Investigational Site Number 840351, Sarasota

35033

Investigational Site Number 250306, Rennes

35801

Investigational Site Number 840321, Huntsville

39120

Investigational Site Number 276301, Magdeburg

41013

Investigational Site Number 724313, Seville

41345

Investigational Site Number 752302, Gothenburg

43204

Investigational Site Number 724304, Tarragona

43302

Investigational Site Number 840302, Marion

44093

Investigational Site Number 250302, Nantes

45227

Investigational Site Number 840340, Cincinnati

46930

Investigational Site Number 724315, Quart de Poblet

50009

Investigational Site Number 724302, Zaragoza

52242

Investigational Site Number 840333, Iowa City

52621

Investigational Site Number 376301, Tel Litwinsky

54121

Investigational Site Number 203309, Trutnov

58100

Investigational Site Number 376302, Holon

58455

Investigational Site Number 276307, Witten

59037

Investigational Site Number 250304, Lille

60181

Investigational Site Number 840305, Oakbrook Terrace

60201

Investigational Site Number 840315, Evanston

60596

Investigational Site Number 276305, Frankfurt A.M.

63110

Investigational Site Number 840317, St Louis

63136

Investigational Site Number 840349, St Louis

66100

Investigational Site Number 380302, Chieti

66160

Investigational Site Number 840329, Kansas City

67100

Investigational Site Number 246301, Kokkola

68601

Investigational Site Number 203304, Uherské Hradiště

75013

Investigational Site Number 250301, Paris

75216

Investigational Site Number 840311, Dallas

75226

Investigational Site Number 840312, Dallas

76104

Investigational Site Number 840301, Fort Worth

76275

Investigational Site Number 203302, Zlín

80100

Investigational Site Number 246302, Joensuu

80131

Investigational Site Number 380303, Napoli

80401

Investigational Site Number 840306, Golden

84010

Investigational Site Number 840343, Bountiful

85282

Investigational Site Number 840341, Tempe

90048

Investigational Site Number 840336, Los Angeles

90127

Investigational Site Number 380301, Palermo

90201

Investigational Site Number 840334, Bell Gardens

91120

Investigational Site Number 376304, Jerusalem

92663

Investigational Site Number 840337, Newport Beach

92691

Investigational Site Number 840339, Mission Viejo

92708

Investigational Site Number 840319, Fountain Valley

97239

Investigational Site Number 840330, Portland

99204

Investigational Site Number 840350, Spokane

111539

Investigational Site Number 643302, Moscow

121552

Investigational Site Number 643308, Moscow

129301

Investigational Site Number 643305, Moscow

163000

Investigational Site Number 643304, Arkhangelsk

194156

Investigational Site Number 643301, Saint Petersburg

194291

Investigational Site Number 643306, Saint Petersburg

196084

Investigational Site Number 643312, Saint Petersburg

300358

Investigational Site Number 642302, Timișoara

420012

Investigational Site Number 643303, Kazan'

630089

Investigational Site Number 643310, Novosibirsk

33308-4311

Investigational Site Number 840318, Fort Lauderdale

04210

Investigational Site Number 840345, Auburn

04005

Investigational Site Number 840338, Biddeford

02114

Investigational Site Number 840322, Boston

01702

Investigational Site Number 840346, Framingham

07901

Investigational Site Number 840314, Morristown

C1119ACN

Investigational Site Number 032302, Caba

B7540GHD

Investigational Site Number 032301, Coronel Suárez

G7H 7K9

Investigational Site Number 124303, Chicoutimi

H1W 2R7

Investigational Site Number 124302, Montreal

G1V 4W2

Investigational Site Number 124301, Québec

J1H 5N4

Investigational Site Number 124306, Sherbrooke

M5C 2T2

Investigational Site Number 124305, Toronto

V8T 5G4

Investigational Site Number 124304, Victoria

500 05

Investigational Site Number 203307, Hradec Králové

180 81

Investigational Site Number 203303, Prague

01600

Investigational Site Number 246304, Vantaa

04103

Investigational Site Number 276306, Leipzig

03300

Investigational Site Number 484301, México

1815 JD

Investigational Site Number 528317, Alkmaar

1105 AZ

Investigational Site Number 528301, Amsterdam-Zuidoost

7314 ET

Investigational Site Number 528320, Apeldoorn

9934 JD

Investigational Site Number 528309, Delfzijl

5616GB

Investigational Site Number 528313, Eindhoven

7513 ER

Investigational Site Number 528319, Enschede

4462 RA

Investigational Site Number 528322, Goes

9713 GZ

Investigational Site Number 528325, Groningen

9728 NT

Investigational Site Number 528302, Groningen

7909 AA

Investigational Site Number 528324, Hoogeveen

1624 NP

Investigational Site Number 528318, Hoorn

2333 ZA

Investigational Site Number 528305, Leiden

6229 HX

Investigational Site Number 528311, Maastricht

6500 HB

Investigational Site Number 528312, Nijmegen

3021 HC

Investigational Site Number 528315, Rotterdam

3045 PM

Investigational Site Number 528326, Rotterdam

3582 KE

Investigational Site Number 528303, Utrecht

3584 CX

Investigational Site Number 528323, Utrecht

5912 BL

Investigational Site Number 528321, Venlo

5141 BM

Investigational Site Number 528316, Waalwijk

0407

Investigational Site Number 578305, Oslo

Unknown

Investigational Site Number 578304, Oslo

Investigational Site Number 710308, Witbank

9004-514

Investigational Site Number 620302, Funchal

1169-024

Investigational Site Number 620301, Lisbon

0158

Investigational Site Number 710309, Centurion

0002

Investigational Site Number 710313, Pretoria

0084

Investigational Site Number 710303, Pretoria

0157

Investigational Site Number 710305, Pretoria

0184

Investigational Site Number 710314, Pretoria

08036

Investigational Site Number 724308, Barcelona

08907

Investigational Site Number 724307, L'Hospitalet de Llobregat

08208

Investigational Site Number 724310, Sabadell

111 35

Investigational Site Number 752301, Stockholm

B15 2SQ

Investigational Site Number 826318, Birmingham

BN1 9PH

Investigational Site Number 826304, Brighton

BS2 8HW

Investigational Site Number 826301, Bristol

CB2 OQQ

Investigational Site Number 826311, Cambridge

CF14 5GJ

Investigational Site Number 826310, Cardiff

DD1 9SY

Investigational Site Number 826302, Dundee

L22 0LG

Investigational Site Number 826317, Liverpool

L7 8XP

Investigational Site Number 826306, Liverpool

M13 9WL

Investigational Site Number 826312, Manchester

M23 9LT

Investigational Site Number 826303, Manchester

HA6 2RN

Investigational Site Number 826305, Middlesex

NEI 4LP

Investigational Site Number 826313, Newcastle upon Tyne

RG2 0TG

Investigational Site Number 826309, Reading

B71 4HJ

Investigational Site Number 826315, West Bromwich

Investigational Site Number 826316, West Bromwich

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT01954394 - Open Label Study of Long Term Safety Evaluation of Alirocumab | Biotech Hunter | Biotech Hunter