NCT02107898 - Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN) | Biotech Hunter

Enrollment

216

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

September 30, 2015

Conditions

Hypercholesterolemia

Interventions

DRUG

Placebo (for alirocumab)

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.

DRUG

Alirocumab

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.

DRUG

Lipid-Modifying Therapy (LMT)

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

Trial Locations (32)

Unknown

Investigational Site Number 392016, Adachi-Ku

Investigational Site Number 392029, Adachi-Ku

Investigational Site Number 392024, Aki-Gun

Investigational Site Number 392012, Chūōku

Investigational Site Number 392013, Chūōku

Investigational Site Number 392032, Fukui-shi

Investigational Site Number 392004, Hakusan-Shi

Investigational Site Number 392028, Kaga-Shi

Investigational Site Number 392002, Kanazawa

Investigational Site Number 392005, Kanazawa

Investigational Site Number 392023, Kawanishi-Shi

Investigational Site Number 392009, Kisarazu-Shi

Investigational Site Number 392026, Kitakyushu-Shi

Investigational Site Number 392003, Komatsu-Shi

Investigational Site Number 392011, Kuki-Shi

Investigational Site Number 392017, Matsumoto-Shi

Investigational Site Number 392007, Mito

Investigational Site Number 392006, Moriya-Shi

Investigational Site Number 392018, Nagoya

Investigational Site Number 392014, Oota-Ku

Investigational Site Number 392019, Osaka

Investigational Site Number 392020, Osaka

Investigational Site Number 392022, Osaka

Investigational Site Number 392030, Osaka

Investigational Site Number 392027, Oyabe-Shi

Investigational Site Number 392010, Saitama-Shi

Investigational Site Number 392015, Shinjuku-Ku

Investigational Site Number 392031, Shizuoka

Investigational Site Number 392021, Suita-Shi

Investigational Site Number 392025, Takamatsu

Investigational Site Number 392008, Tsuchiura-Shi

Investigational Site Number 392001, Yamagata