Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01709500
Phase
PHASE3
Status
Completed

Conditions

  • Heterozygous Familial Hypercholesterolemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LMT (atorvastatin, simvastatin, or rosuvastatin) — DRUG
  • alirocumab — DRUG
    Alirocumab administered as a subcutaneous (SC) injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
  • Placebo — DRUG
    Placebo matched to alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.

Study Details

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).

Key Dates

Start date
Dec 31, 2012
Status verified
Sep 2015
Primary completion
May 31, 2014
Completion
Jan 31, 2015

Study Design

Enrollment
249 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab 75 mg/up to 150 mg
    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.
  • Placebo Comparator: Placebo
    Placebo matched to alirocumab SC injection for 78-week treatment duration.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis [ Time Frame: From Baseline to Week 52 ]

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