Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab SAR236553; Current auto-injector device (AI); New auto-injector device (SYDNEY); Atorvastatin; Rosuvastatin
Intervention description: Pharmaceutical form: Solution for injection Route of administration: Subcutaneous; Pharmaceutical form:
Route of administration: Subcutaneous self-administration of alirocumab; Pharmaceutical form:
Route of administration: Subcutaneous self-administration of alirocumab; Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:tablet Route of administration: oral
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To collect real-use (usability) data assessing the robustness and user interaction of the new
      alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings.

      Secondary Objective:

      Device-related:

        -  To collect real-use (usability) data assessing the robustness and user interaction of
           SYDNEY and the current alirocumab auto-injector device (which is referred to as AI) in
           supervised settings.

      Pharmacokinetics:

        -  To compare alirocumab pharmacokinetics (PK) administered using SYDNEY and AI.

        -  To evaluate alirocumab PK administered using SYDNEY.

      Anti-drug antibodies:

        -  To evaluate the development of anti-drug (alirocumab) antibodies (ADA).

      Efficacy/pharmacodynamics:

        -  To compare the percent and absolute change in low-density lipoprotein cholesterol
           (LDL-C) using SYDNEY and AI.

        -  To evaluate the percent and absolute change in LDL-C using SYDNEY.

      Safety:

        -  To evaluate the safety and tolerability of alirocumab using both SYDNEY and AI.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants were in either category A or B (below), and were not adequately
             controlled with a stable daily dose of atorvastatin (20 mg or 40 mg), or rosuvastatin
             (10 mg or 20 mg) for at least 4 weeks prior to the screening visit (Week -2), with or
             without other LMT:

               -  A. Participants with heterozygous familial hypercholesterolemia (heFH) (diagnosis
                  based on either genotyping or clinical criteria) OR

               -  B. Non-FH Participants at high or very high cardiovascular (CV) risk. High and
                  very high cardiovascular risk participants included participants with coronary
                  heart disease (CHD), non-CHD cardiovascular disease (CVD), and other risk
                  factors.

          -  Participant willing and able to self-inject for the duration of the study.

        Exclusion criteria:

          -  LDL-C <70 milligrams per deciliter (mg/dL) (<1.81 millimoles per litre [mmol/L]) at
             the screening visit.

          -  Currently taking a daily dose of statin that was not atorvastatin 20 mg or 40 mg, or
             rosuvastatin 10 mg or 20 mg.

          -  Not on a stable dose of LMT (including statin) for at least 4 weeks, prior to the
             screening visit and from screening to randomization.

          -  Having previously used any device for the proprotein convertase subtilisin/kexin type
             9 (PCSK9) inhibitor administration, or having participated in any clinical trial for a
             PCSK9 inhibitor.

          -  Fasting serum Triglyceride (TG) >400 mg/dL (>4.52 mmol/L) at the screening visit.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.