NCT01617655 - Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) | Biotech Hunter

Enrollment

107

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

January 31, 2015

Conditions

Hypercholesterolaemia

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 (35)

2193

Investigational Site Number 710702, Parktown

7130

Investigational Site Number 710703, Somerset West

7530

Investigational Site Number 710706, Cap Town

9301

Investigational Site Number 710701, Bloemfontein

Investigational Site Number 710704, Bloemfontein

10032

Investigational Site Number 840701, New York

19104

Investigational Site Number 840705, Philadelphia

Investigational Site Number 840709, Philadelphia

Investigational Site Number 840713, Philadelphia

20037

Investigational Site Number 840734, Washington D.C.

27710

Investigational Site Number 840702, Durham

32081

Investigational Site Number 840710, Ponte Vedra

33165

Investigational Site Number 840738, Miami

45219

Investigational Site Number 840714, Cincinnati

75216

Investigational Site Number 840736, Dallas

90201

Investigational Site Number 840742, Bell Gardens

91324

Investigational Site Number 840743, Northridge

92660

Investigational Site Number 840703, Newport Beach

92663

Investigational Site Number 840712, Newport Beach

111539

Investigational Site Number 643703, Moscow

121552

Investigational Site Number 643711, Moscow

129301

Investigational Site Number 643708, Moscow

150062

Investigational Site Number 643707, Yaroslavl

163000

Investigational Site Number 643706, Arkhangelsk

193079

Investigational Site Number 643710, Saint Petersburg

194291

Investigational Site Number 643709, Saint Petersburg

197341

Investigational Site Number 643702, Saint Petersburg

420012

Investigational Site Number 643705, Kazan'

G1V 4M6

Investigational Site Number 124704, Québec

J1H 5N4

Investigational Site Number 124703, Sherbrooke

1091 AC

Investigational Site Number 528713, Amsterdam

1105 AZ

Investigational Site Number 528701, Amsterdam

9728 NT

Investigational Site Number 528704, Groningen

2333 ZA

Investigational Site Number 528716, Leiden

3582 KE

Investigational Site Number 528709, Utrecht