NCT01623115 - Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy | Biotech Hunter

Enrollment

486

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

December 31, 2014

Conditions

Hypercholesterolemia

Interventions

DRUG

Alirocumab

Solution for subcutaneous 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 subcutaneous 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

Lipid Modifying Therapy (LMT)

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

Trial Locations (91)

1130

Investigational Site Number 040402, Vienna

2193

Investigational Site Number 710407, Parktown

6700

Investigational Site Number 208403, Esbjerg

7130

Investigational Site Number 710409, Somerset West

7500

Investigational Site Number 710403, Parow

7530

Investigational Site Number 710406, Cap Town

7708

Investigational Site Number 710402, Cape Town

8036

Investigational Site Number 040403, Graz

8092

Investigational Site Number 578401, Bodø

10032

Investigational Site Number 840408, New York

13100

Investigational Site Number 376404, Safed

14004

Investigational Site Number 724406, Córdoba

15006

Investigational Site Number 724403, A Coruña

19104

Investigational Site Number 840404, Philadelphia

Investigational Site Number 840426, Philadelphia

20037

Investigational Site Number 840452, Washington D.C.

21000

Investigational Site Number 250403, Dijon

27710

Investigational Site Number 840410, Durham

28029

Investigational Site Number 724409, Madrid

28040

Investigational Site Number 724401, Madrid

Investigational Site Number 724405, Madrid

28207

Investigational Site Number 840401, Charlotte

32081

Investigational Site Number 840418, Ponte Vedra

33165

Investigational Site Number 840456, Miami

37232

Investigational Site Number 840406, Nashville

41345

Investigational Site Number 752404, Gothenburg

43201

Investigational Site Number 724404, Reus

44093

Investigational Site Number 250402, Saint-Herblain

45219

Investigational Site Number 840430, Cincinnati

50009

Investigational Site Number 724402, Zaragoza

52621

Investigational Site Number 376401, Tel Litwinsky

60201

Investigational Site Number 840455, Evanston

63110

Investigational Site Number 840409, St Louis

75216

Investigational Site Number 840460, Dallas

75651

Investigational Site Number 250401, Paris

76100

Investigational Site Number 376402, Holon

84010

Investigational Site Number 840422, Bountiful

90048

Investigational Site Number 840419, Los Angeles

90201

Investigational Site Number 840417, Bell Gardens

90801

Investigational Site Number 840429, Long Beach

91324

Investigational Site Number 840461, Northridge

92660

Investigational Site Number 840412, Newport Beach

92691

Investigational Site Number 840421, Mission Viejo

111539

Investigational Site Number 643409, Moscow

121552

Investigational Site Number 643413, Moscow

129301

Investigational Site Number 643401, Moscow

150062

Investigational Site Number 643410, Yaroslavl

163000

Investigational Site Number 643402, Arkhangelsk

193079

Investigational Site Number 643408, Saint Petersburg

194291

Investigational Site Number 643406, Saint Petersburg

197341

Investigational Site Number 643404, Saint Petersburg

420012

Investigational Site Number 643407, Kazan'

Unknown

Investigational Site Number 840428, Newport Beach

Investigational Site Number 040405, Vienna

Investigational Site Number 203405, Uherské Hradiště

Investigational Site Number 208401, Copenhagen

Investigational Site Number 376405, Jerusalem

Investigational Site Number 528410, Amsterdam

Investigational Site Number 528412, Sliedrecht

Investigational Site Number 643412, Novisibirsk

Investigational Site Number 710401, Bloemfontein

Investigational Site Number 710405, Bloemfontein

Investigational Site Number 710408, Pretoria

Investigational Site Number 710404, Rondebosch

Investigational Site Number 826402, London

Investigational Site Number 826403, London

Investigational Site Number 826408, London

Investigational Site Number 826409, London

66160-7321

Investigational Site Number 840415, Kansas City

04210

Investigational Site Number 840425, Auburn

02114

Investigational Site Number 840411, Boston

07962

Investigational Site Number 840407, Morristown

97201-3098

Investigational Site Number 840424, Portland

G7H 5H6

Investigational Site Number 124404, Chicoutimi

H2W 1R7

Investigational Site Number 124401, Montreal

G1V 4M6

Investigational Site Number 124403, Québec

J1H 5N4

Investigational Site Number 124406, Sherbrooke

M5C 2T2

Investigational Site Number 124407, Toronto

140 00

Investigational Site Number 203401, Prague

180 00

Investigational Site Number 203403, Prague

760 00

Investigational Site Number 203402, Zlín

1105 AZ

Investigational Site Number 528406, Amsterdam

1782 GZ

Investigational Site Number 528408, Den Helder

9728 NT

Investigational Site Number 528402, Groningen

2333 ZA

Investigational Site Number 528411, Leiden

6229 HX

Investigational Site Number 528416, Maastricht

3435 CM

Investigational Site Number 528409, Nieuwegein

08036

Investigational Site Number 724408, Barcelona

08907

Investigational Site Number 724407, L'Hospitalet de Llobregat

111 35

Investigational Site Number 752401, Stockholm

M23 9LT

Investigational Site Number 826405, Manchester