NCT02584504 - Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin | Biotech Hunter

Enrollment

163

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

April 5, 2017

Study Completion Date

January 9, 2018

Conditions

Hypercholesterolemia

Interventions

DRUG

Alirocumab

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

DRUG

Placebo

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

DRUG

Atorvastatin

Atorvastatin 5 mg tablet orally.

DRUG

Non-statin Lipid-Modifying Therapy

Ezetimibe, Bezafibrate or Fenofibrate at stable dose as background therapy.

OTHER

Diet Alone

Stable cholesterol-lowering diet as background therapy.

Trial Locations (30)

Unknown

Investigational Site Number 392028, Ageo-Shi

Investigational Site Number 392007, Chūōku

Investigational Site Number 392029, Chūōku

Investigational Site Number 392014, Fukui-shi

Investigational Site Number 392023, Hachioji-Shi

Investigational Site Number 392013, Itoshima-Shi

Investigational Site Number 392010, Kanazawa

Investigational Site Number 392024, Kasuga-Shi

Investigational Site Number 392004, Kawanishi-Shi

Investigational Site Number 392015, Kitakyushu-Shi

Investigational Site Number 392005, Komatsu-Shi

Investigational Site Number 392032, Matsudo-Shi

Investigational Site Number 392017, Matsumoto-Shi

Investigational Site Number 392003, Mito

Investigational Site Number 392018, Morioka

Investigational Site Number 392009, Moriya-Shi

Investigational Site Number 392006, Nagoya

Investigational Site Number 392011, Nagoya

Investigational Site Number 392019, Nagoya

Investigational Site Number 392025, Nagoya

Investigational Site Number 392027, Osaka

Investigational Site Number 392030, Sakura-Shi

Investigational Site Number 392016, Shinagawa-Ku

Investigational Site Number 392001, Shinjuku-Ku

Investigational Site Number 392008, Shinjuku-Ku

Investigational Site Number 392012, Shizuoka

Investigational Site Number 392002, Suita-Shi

Investigational Site Number 392031, Suita-Shi

Investigational Site Number 392020, Toyonaka-Shi

Investigational Site Number 392022, Yakushi