Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Placebo (for Alirocumab); Alirocumab; Lipid-Modifying Therapy (LMT)
Intervention description: Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.; Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.; Statins (Rosuvastatin, Simvastatin or Atorvastatin) 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: 199.0
Sex: All
Minimum age: 18 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 maximally tolerated daily statin therapy with or without other
      lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high
      cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan.

      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: apolipoprotein B (Apo
           B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC),
           lipoprotein (a) (Lp [a]), high-density lipoprotein cholesterol (HDL-C), triglycerides
           (TGs), and apolipoprotein A-1 (Apo A-1).

        -  To evaluate the safety and tolerability of alirocumab.

        -  To evaluate the development of anti-alirocumab antibodies (ADA).
    

Eligibility criteria:

        Inclusion criteria:

        Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD
        risk equivalents who are not adequately controlled with a maximally tolerated daily dose of
        statin with or without other LMT, both at stable dose for at least 4 weeks prior to
        screening visit (Week -3).

        Exclusion criteria:

          -  Aged <18 years or legal age of adulthood, whichever was greater.

          -  Participants without established CHD or CHD risk equivalent.

          -  LDL-C <70 mg/dL (<1.81 mmol/L) in participants with a history of documented
             cardiovascular disease.

          -  LDL-C <100 mg/dL (<2.59 mmol/L) in participants without a history of documented
             cardiovascular disease.

          -  Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the
             screening visit (Week -3) or between screening to randomization visits.

          -  Currently taking a statin other than atorvastatin, rosuvastatin or simvastatin.

          -  Atorvastatin, rosuvastatin or simvastatin was not taken daily or not taken at a
             registered dose.

          -  Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or simvastatin 40 mg.

          -  Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) at the screening period.

        The above information is not intended to contain all considerations relevant to a
        participants's potential participation in a clinical trial.