Clinical Trials List
2015-10-02 - 2019-03-31
Phase II
Terminated6
ICD-10E78.0
Pure hypercholesterolemia
ICD-10E78.5
Hyperlipidemia, unspecified
A Prospective, Double Blind, Randomized, Placebo-controlled Trial of Antroquinonol in Patients with Hypercholesterolemia and Hyperlipidemia
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Trial Applicant
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Sponsor
Golden Biotechnology Corporation
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 何弘棋 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Po-Sheng Chen Division of Cardiovascular Diseases
- Yen-Wen Liu Division of Cardiovascular Diseases
- 李文煌 Division of Cardiovascular Diseases
- Ju-Yi Chen Division of Cardiovascular Diseases
- Po-Tseng Lee Division of Cardiovascular Diseases
- Cheng-Han Lee Division of Cardiovascular Diseases
- 黃成偉 Division of Cardiovascular Diseases
- 林志展 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Wen-Chung Yu Division of Cardiovascular Diseases
- Hao-min Cheng Division of Cardiovascular Diseases
- 許百豐 Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- JYH-MING JIMMY JUANG Division of Cardiovascular Diseases
- Juey-Jen Hwang Division of Cardiovascular Diseases
- LIAN-YU LIN Division of Cardiovascular Diseases
- 江福田 Division of Cardiovascular Diseases
- Yi-Chih Wang Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary efficacy endpoint is the percentage change of TG by Antroquinonol, in
comparison with placebo, after 12 weeks of treatment in patients with
hypercholesterolemia and hyperlipidemia.
2. Secondary endpoints:
Secondary endpoints include the evaluation of the effect of Antroquinonol in
comparison with placebo on total cholesterol, HDL-C, LDL-C and HDL/LDL ratio after 12
weeks of treatment; 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; in addition, the effect of
Antroquinonol on the fatty liver prognostic with CT scan.
Inclution Criteria
(1) Adults of either sex 30 to 75 years of age, inclusive, with a diagnosis of primary
hypercholesterolemia (nonfamilial) 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 primary
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 lipidlowering 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 hyperlipidemia;
(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 previous history of coronary artery disease;
(4) Patient has a known hypersensitivity to Antroquinonol or related compounds;
(5) 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;
(6) Patients with a history of heart transplant or who are on a transplant list or with
left ventricular assistance device (LVAD device);
(7) Patients with documented ventricular arrhythmia with syncopal episodes within
the past 3 months prior to visit 1 that remained untreated;
(8) Patients with confirmed severe primary pulmonary, renal (eGFR<30 ml/min/1.73 m2)
or hepatic (Child-Pugh B/C classification) disease;
(9) Female patient during pregnancy, lactation or breastfeeding;
(10)Patient has any other life-threatening complications;
(11)Patient who is considered unreliable as to medication compliance or adherence to
scheduled appointments, or inappropriate for inclusion determined by the
investigators;
(12)Any other reasons addressed by the investigators.
The Estimated Number of Participants
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Taiwan
120 participants
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Global
0 participants
