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Trial record 6 of 9 for:    antroquinonol

Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia

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ClinicalTrials.gov Identifier: NCT02719028
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : December 20, 2019
Last Update Posted : January 2, 2020
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.

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : September 27, 2018
Actual Study Completion Date : March 31, 2019

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 ]
    value at 12 weeks minus value at baseline


Secondary Outcome Measures :
  1. LDL& HDL (mg/dL) [ Time Frame: 12 weeks ]
    value at 12 weeks minus value at baseline of PP pupulation in HDL/LDL ratio.

  2. Non-invasive Arterial Stiffness Measurement [ Time Frame: 12 weeks ]
    To evaluate the effect of Antroquinonol via a non-invasive arterial stiffness measurement.

  3. Fatty Liver [ Time Frame: 12 weeks ]
    To evaluate the recover fatty liver effect of Antroquinonol on patients who with fatty liver by Investigator



Information from the National Library of Medicine

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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


Locations
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Taiwan
Chang Gung Memorial Hospital, Linkou branch
New Taipei City, Taiwan
Far Eastern Memorial Hospital
New Taipei city, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Golden Biotechnology Corporation
Investigators
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Principal Investigator: Fu-Tien Chiang, M.D. National Taiwan University Hopspital
  Study Documents (Full-Text)

Documents provided by Golden Biotechnology Corporation:
Statistical Analysis Plan  [PDF] February 9, 2018
Study Protocol  [PDF] February 3, 2017


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Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT02719028    
Other Study ID Numbers: GHLIP-2-001
First Posted: March 25, 2016    Key Record Dates
Results First Posted: December 20, 2019
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs