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)
Condition: Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Placebo (for alirocumab); Alirocumab; Lipid-Modifying Therapy (LMT)
Intervention description: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.; Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.; Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as
      add-on therapy to stable daily statin therapy with or without other lipid modifying therapy
      in comparison with placebo after 24 weeks of treatment in heterozygous familial
      hypercholesterolemia (HeFH) or high cardiovascular risk participants with
      hypercholesterolemia.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks
           of treatment.

        -  To evaluate the effect of alirocumab on other lipid parameters.

        -  To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after
           52 weeks of treatment.

        -  To evaluate the safety and tolerability of alirocumab.

        -  To evaluate the development of anti-alirocumab antibodies.

        -  To evaluate the pharmacokinetics of alirocumab.
    

Eligibility criteria:

        Inclusion criteria:

        Participants with heterozygous familial hypercholesterolemia or non-familial
        hypercholesterolemia who were not adequately controlled with a stable daily dose of statin
        with or without other lipid modifying therapy, at stable dose prior to the screening visit
        (Week -3).

        Exclusion criteria:

          1. LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit in participants with
             heterozygous familial hypercholesterolemia or in participants with non-familial
             hypercholesterolemia who had a history of documented coronary heart disease as
             described in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of
             Atherosclerotic Cardiovascular Diseases 2012.

          2. LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit in participants with
             non-familial hypercholesterolemia who had a history of documented diseases or other
             risk factors as categorized in primary prevention category III as described in JAS
             Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.

          3. Not on a stable daily dose of lipid modifying therapy (including statin) within 4
             weeks prior to the screening visit or between screening and randomization visits.

          4. Age <20 years at the screening visit.

        The above information is not intended to contain all considerations relevant to a
        participants' potential participation in a clinical trial.