Clinical trial NCT02719028: Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
Official title: A Prospective, Double Blind, Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemias
Lead sponsor: Golden Biotechnology Corporation
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The primary efficacy objective is to demonstrate the reduction of triglyceride (TG) by Antroquinonol, in comparison with placebo, after 12 weeks of treatment in patients with hypercholesterolemia and hyperlipidemia. Secondary objectives include the evaluation of the effects of Antroquinonol in comparison with placebo on other lipid parameters after 12 weeks of treatment and the effects of Antroquinonol on left ventricular diastolic function, arterial stiffness and fatty liver. The safety and tolerability of Antroquinonol will be monitored as well.

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.

Primary outcomes:
measure: TG Change (mg/dL )
timeFrame: 12 weeks
Secondary outcomes:
measure: LDL& HDL (mg/dL)
timeFrame: 12 weeks
measure: Non-invasive Arterial Stiffness Measurement
timeFrame: 12 weeks
measure: Fatty Liver
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou branch
city: New Taipei city
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Taiwan University Hopspital
name: Fu-Tien Chiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: