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Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia

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ClinicalTrials.gov Identifier: NCT02719028
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation

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

Condition or disease Intervention/treatment Phase
Hyperlipidemias Drug: Antroquinonol Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double Blind, Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg or Placebo) 3 capsules once a day.
Drug: placebo
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)

Experimental: Antroquinonol 50 mg PO
Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg or Placebo) 3 capsules once a day.
Drug: Antroquinonol
Antroquinonol will be provided as capsules of 50 mg
Other Name: Hocena 50mg

Drug: placebo
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)

Experimental: Antroquinonol 100 mg PO
Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg or Placebo) 3 capsules once a day.
Drug: Antroquinonol
Antroquinonol will be provided as capsules of 50 mg
Other Name: Hocena 50mg

Drug: placebo
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)

Experimental: Antroquinonol 150 mg PO
Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg or Placebo) 3 capsules once a day.
Drug: Antroquinonol
Antroquinonol will be provided as capsules of 50 mg
Other Name: Hocena 50mg




Primary Outcome Measures :
  1. TG change (mg/dL ) [ Time Frame: 12 weeks ]
    in comparison with placebo, after 12 weeks of treatment in patients with hypercholesterolemia and hyperlipidemia.


Secondary Outcome Measures :
  1. LDL& HDL (mg/dL) [ Time Frame: 12 weeks ]
    To evaluate the effect of 12 weeks of oral administration Antroquinonol compared with placebo, on percent change from baseline in total cholesterol, HDL-C, LDL-C, HDL/LDL ratio as lipid-lowering therapy.

  2. Non-invasive arterial stiffness measurement [ Time Frame: 12 weeks ]
    To evaluate the effect of Antroquinonol on the ratio of mitral velocity to early diastolic velocity of the mitral annulus (E/E' ratio) with tissue Doppler imaging and cfPWV via a non-invasive arterial stiffness measurement.

  3. Fatty level in The Hounsfield Unit (HU) [ Time Frame: 12 weeks ]
    To evaluate the effect of Antroquinonol on fatty liver via computed tomography (CT) scanning.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719028


Contacts
Contact: Howard Cheng, Ph.D. 886-2-28086006 howard@goldenbiotech.com.tw
Contact: Anny Cai, MS 886-2-28086006

Locations
Taiwan
Chang Gung Memorial Hospital, Linkou branch Active, not recruiting
New Taipei City, Taiwan
Far Eastern Memorial Hospital Recruiting
New Taipei city, Taiwan
Contact: Yen-Wen Wu, M.D.         
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Jin-Jer Chen, M.D.         
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Ping-Yen Liu, M.D.         
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Cho-Kai Wu, MD         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Chen-Huan Chen, M.D.         
Sponsors and Collaborators
Golden Biotechnology Corporation
Investigators
Principal Investigator: Fu-Tien Chiang, M.D. National Taiwan University Hopspital

Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT02719028     History of Changes
Other Study ID Numbers: GHLIP-2-001
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs