Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
Condition: Hyperlipidemias
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Antroquinonol; placebo
Intervention description: Antroquinonol will be provided as capsules of 50 mg; The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Identified the efficacy of Antroquinonol (Hocena 50mg) in triglyceride, lipid-lowering and
      fatty liver.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults of either sex 30 to 75 years of age, inclusive, with a diagnosis of nonfamilial
             hypercholesterolemia or mixed hyperlipidemia as one of the following:

               -  TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250
                  mg/dL

               -  TG between 150 mg/dL and 500 mg/dL and LDL-C > 130 mg/dL);

          2. Subject must be free of any clinically significant disease, other than nonfamilial
             hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study
             evaluations;

          3. A wash-out period of 2 weeks will be applied to patients prior treated with
             lipid-lowering medication;

          4. Subject must be willing to adhere to protocol requirements, and provide written
             informed consent;

          5. Female of child-bearing potential must agree to use adequate contraception (hormonal
             or barrier method of birth control; abstinence) prior to study entry and for the
             duration of study participation.

        Exclusion Criteria:

          1. Patients with secondary dyslipidemia caused by diabetes mellitus, hypothyroidism,
             obstructive liver disease, chronic renal failure or drugs which can increase LDL-C
             level (e.g. retinoids, cyclosporine A and phenothiazines) or decrease HDL-C level
             (e.g. progestins, androgens, β-blockers, probucol and anabolic steroid)

          2. Patients with lifestyle that may interfere treatment efficacy, such as alcoholism or
             drinking habits more than 3 times per week, late dinner, late night supper, frequent
             oversea business traveler, frequent social gathering, and patients who cannot
             anticipate a diet control and lifestyle changes;

          3. Patients with diabetes or history of coronary artery disease (has had myocardial
             infarction, cardiac intervention, cerebrovascular accident/stroke or transient
             ischemic attack less than 6 months prior to Visit 1);

          4. Patients with hypertension that is uncontrolled defined as 2 consecutive measurements
             of sitting blood pressure of systolic >140 mmHg or diastolic > 90 mmHg at Visit 1;

          5. Patient has a known hypersensitivity to Antroquinonol or related compounds;

          6. Patient with uncontrolled intercurrent illness including, but not limited to, acute
             decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may
             require IV therapy), right heart failure due to severe pulmonary disease, diagnosed
             peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to visit
             1, or psychiatric illness/social situations that would limit compliance with study
             requirements;

          7. Patients with a history of heart transplant or who are on a transplant list or with
             left ventricular assistance device (LVAD device);

          8. Patients with documented ventricular arrhythmia with syncopal episodes within the past
             3 months prior to visit 1 that remained untreated;

          9. Patients with confirmed severe primary pulmonary, renal (eGFR<30 ml/min/1.73 m2) or
             hepatic (Child-Pugh B/C classification) disease;

         10. Patients who can't stop current lipid lowering drug treatments based on investigator's
             judgement;

         11. Patients with any malignancy, treated or untreated, within the past 5 years of Visit 1
             whether or not there is evidence of local recurrence or metastases, with the exception
             of localized basal cell carcinoma of the skin or carcinoma in situ of the cervix;

         12. Female patient during pregnancy, lactation or breastfeeding;

         13. Patient has any other life-threatening complications;

         14. Patient who is considered unreliable as to medication compliance or adherence to
             scheduled appointments, or inappropriate for inclusion determined by the
             investigators;

         15. Any other reasons addressed by the investigators.