Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Placebo (for alirocumab); Alirocumab; Statin
Intervention description: Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.; Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.; Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was conducted in 2 separate populations concurrently: subjects receiving concomitant statin therapy and subjects not receiving concomitant statin therapy. Subjects receiving concomitant statin were to receive stable daily doses of rosuvastatin, atorvastatin, or simvastatin for at least 4 weeks. Background treatment with other lipid-modifying therapy (LMT) was allowed for all patients, provided they had been on a stable dose for at least 4 weeks (6 weeks for fenofibrate) prior to study entry.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 803.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4
      weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The
      dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a
      calibrator.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women > age 18 or legal age of majority with elevated LDL-C

          2. Patients not having adequate control of their hypercholesterolemia based on their
             individual level of CVD risk

          3. Willing and able to comply with clinic visits and study-related procedures

          4. Provided signed informed consent

        Exclusion Criteria:

          1. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable
             angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary
             artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient
             ischemic attack, carotid revascularization, endovascular procedure or surgical
             intervention for peripheral vascular disease

          2. Known history of positive test for human immunodeficiency virus (HIV)

          3. Any clinically significant abnormality identified at the time of screening that in the
             judgment of the investigator or any sub-investigator would preclude safe completion of
             the study or constrain assessment of endpoints, such as major systemic diseases or
             participants with short life expectancy.

          4. Participants considered by the investigator or any sub-investigator to be
             inappropriate for this study (e.g, geographic or social), actual or anticipated, that
             the investigator felt would restrict or limit the participant's participation for the
             duration of the study.

          5. Certain laboratory findings obtained during the screening period

        The information listed above is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial and not all inclusion/ exclusion
        criteria are listed.