Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo for alirocumab; ezetimibe; placebo for ezetimibe; atorvastatin; rosuvastatin; simvastatin
Intervention description: Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:capsule Route of administration: oral; Pharmaceutical form:capsule Route of administration: oral; Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:tablet Route of administration: oral
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe; 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: 615.0
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 in comparison to ezetimibe
      10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at
      high cardiovascular (CV) risk.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C
           after 12 weeks of treatment.

        -  To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B
           (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC),
           lipoprotein a (Lp[a]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1).

        -  To evaluate the safety and tolerability of alirocumab.

        -  To evaluate the development of anti-alirocumab antibodies.

        -  To evaluate the pharmacokinetics (PK) of alirocumab.
    

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 at a stable dose for at least 4 weeks prior to the screening visit (Week -3).

        Exclusion criteria:

          -  Participants without established CHD or CHD risk equivalents.

          -  LDL-C <70 mg/dL (<1.81 mmol/L) at the screening visit (Week -3) in participants with
             history of documented CV disease.

          -  LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in participants
             without history of documented CV disease.

          -  Change in statin dose or dose regimen from screening to randomization.

          -  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 40 mg, or simvastatin 40 mg.

          -  Use of cholesterol absorption inhibitor (ie, ezetimibe), omega-3 fatty acid (at doses
             ≥1000 mg daily), nicotinic acid, fibrates, bile acid-binding sequestrant, or red yeast
             rice products in the past 4 weeks prior to screening visit (Week -3).

          -  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
        participant's potential participation in a clinical trial.