Conditions: Heterozygous Familial Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 249
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).

Detailed description:

Arms:
arm 1: Alirocumab 75 mg every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8. arm 2: Placebo matched to alirocumab SC injection for 78-week treatment duration.

Interventions: intervention 1: LMT (atorvastatin, simvastatin, or rosuvastatin) intervention 2: alirocumab intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: Alirocumab administered as a subcutaneous (SC) injection of 1 mL into the abdomen, thigh, or outer area of the upper arm. intervention 3: Placebo matched to alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.

Protocol document: