Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo; Atorvastatin; Non-statin Lipid-Modifying Therapy; Diet Alone
Intervention description: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.; Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.; Atorvastatin 5 mg tablet orally.; Ezetimibe, Bezafibrate or Fenofibrate at stable dose as background therapy.; Stable cholesterol-lowering diet as background therapy.
Intervention MeSH terms: Atorvastatin; Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Non-statin LMT; Low dose statin

Summary:

      Primary Objective:

      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab
      administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet
      therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of
      treatment in participants with hypercholesterolemia.

      Secondary Objective:

        -  To evaluate the effect of two treatment regimens 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), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).

        -  To evaluate the safety and tolerability of alirocumab administration.

        -  To evaluate the development of anti-alirocumab antibodies.

        -  To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab
           administration.

        -  To evaluate the long-term safety in participants receiving open-label alirocumab
           administration.
    

Eligibility criteria:

        Inclusion criteria :

        Participants with hypercholesterolemia (heFH or non-FH) receiving non statin LMTs or the
        lowest strength of statin.

        Exclusion criteria:

          -  LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in participants with
             heFH or in participants with non-FH who have a history of documented coronary heart
             disease.

          -  LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit (Week -3) in participants with
             non-FH participants who had a history of documented diseases or other risk factors
             classified as primary prevention category III as defined in JAS Guidelines for
             Prevention of Atherosclerotic Cardiovascular Diseases 2012.

          -  Not on a stable dose of LMT (including diet therapy alone) in the run-in period or the
             screening period.

          -  Fasting serum TGs >400 mg/dL (>4.52 mmol/L) at the screening period.

          -  Systolic blood pressure (BP) >160 mmHg or diastolic BP >100 mmHg at the run-in visit
             (Week -7) or the screening visit (Week -3) or the randomization visit (Week 0).

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.