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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

Tracking Information
First Submitted Date  ICMJE March 10, 2016
First Posted Date  ICMJE March 25, 2016
Results First Submitted Date  ICMJE October 16, 2019
Results First Posted Date  ICMJE December 20, 2019
Last Update Posted Date January 2, 2020
Study Start Date  ICMJE May 2016
Actual Primary Completion Date September 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
TG Change (mg/dL ) [ Time Frame: 12 weeks ]
value at 12 weeks minus value at baseline
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2016)
TG Change (mg/dL ) [ Time Frame: 12 weeks ]
in comparison with placebo, after 12 weeks of treatment in patients with hypercholesterolemia and hyperlipidemia.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • LDL& HDL (mg/dL) [ Time Frame: 12 weeks ]
    value at 12 weeks minus value at baseline of PP pupulation in HDL/LDL ratio.
  • Non-invasive Arterial Stiffness Measurement [ Time Frame: 12 weeks ]
    To evaluate the effect of Antroquinonol via a non-invasive arterial stiffness measurement.
  • Fatty Liver [ Time Frame: 12 weeks ]
    To evaluate the recover fatty liver effect of Antroquinonol on patients who with fatty liver by Investigator
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2016)
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
Official Title  ICMJE A Prospective, Double Blind, Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemias
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: placebo
  • 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.
    Interventions:
    • Drug: Antroquinonol
    • Drug: placebo
  • 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.
    Interventions:
    • Drug: Antroquinonol
    • Drug: placebo
  • 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.
    Intervention: Drug: Antroquinonol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2019
Actual Primary Completion Date September 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02719028
Other Study ID Numbers  ICMJE GHLIP-2-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Golden Biotechnology Corporation
Study Sponsor  ICMJE Golden Biotechnology Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fu-Tien Chiang, M.D. National Taiwan University Hopspital
PRS Account Golden Biotechnology Corporation
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP