Trial Outcomes & Findings for Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia (NCT NCT02719028)
NCT ID: NCT02719028
Last Updated: 2020-01-02
Results Overview
value at 12 weeks minus value at baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-01-02
Participant Flow
A multi-center, phase II, prospective, double blind, randomized, placebo-controlled trial, recruiting from 23-Jun-2016 to 30-Aug-2018 6 sites are NTUniversity Hospital; CMU Hospital; NCKU Hospital; Taipei VG Hospital; FEM Hospital; CGM Hospital, Linkou branch;
total treatment period: 16 weeks including a 2-week screening visit, a 12-week study treatment, and a 2-week follow-up
Participant milestones
| Measure |
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
6
|
10
|
Reasons for withdrawal
| Measure |
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
4
|
8
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
1
|
|
Overall Study
Use of prohibited medication
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
Antroquinonol 50 mg PO
n=30 Participants
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 100 mg PO
n=30 Participants
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 150 mg PO
n=30 Participants
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 15.12 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 13.18 • n=7 Participants
|
48.9 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 9.98 • n=4 Participants
|
50.70 years
STANDARD_DEVIATION 12.37 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
120 participants
n=21 Participants
|
|
BMI
|
28.4 kg/m^2
STANDARD_DEVIATION 4.71 • n=5 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 3.80 • n=7 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 5.41 • n=5 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 3.72 • n=4 Participants
|
27.68 kg/m^2
STANDARD_DEVIATION 4.36 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Per-protocol population
value at 12 weeks minus value at baseline
Outcome measures
| Measure |
Placebo
n=28 Participants
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
Antroquinonol 50 mg PO
n=28 Participants
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 100 mg PO
n=22 Participants
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 150 mg PO
n=20 Participants
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
|---|---|---|---|---|
|
TG Change (mg/dL )
|
-9.2 percentage of change
Interval -17.97 to 12.2
|
14.6 percentage of change
Interval 3.48 to 40.8
|
-4.2 percentage of change
Interval -15.68 to 15.8
|
-1.3 percentage of change
Interval -13.01 to 15.17
|
SECONDARY outcome
Timeframe: 12 weeksvalue at 12 weeks minus value at baseline of PP pupulation in HDL/LDL ratio.
Outcome measures
| Measure |
Placebo
n=28 Participants
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
Antroquinonol 50 mg PO
n=28 Participants
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 100 mg PO
n=22 Participants
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 150 mg PO
n=20 Participants
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
|---|---|---|---|---|
|
LDL& HDL (mg/dL)
|
2.4 percentage of change
Standard Deviation 21.73
|
5.1 percentage of change
Standard Deviation 23.02
|
-1.1 percentage of change
Standard Deviation 15.51
|
0.3 percentage of change
Standard Deviation 13.98
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Per-protocol population
To evaluate the effect of Antroquinonol via a non-invasive arterial stiffness measurement.
Outcome measures
| Measure |
Placebo
n=28 Participants
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
Antroquinonol 50 mg PO
n=28 Participants
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 100 mg PO
n=22 Participants
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 150 mg PO
n=20 Participants
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
|---|---|---|---|---|
|
Non-invasive Arterial Stiffness Measurement
|
3.1 percentage of change
Standard Deviation 9.58
|
0.0 percentage of change
Standard Deviation 13.80
|
-3.3 percentage of change
Standard Deviation 10.38
|
2.8 percentage of change
Standard Deviation 9.84
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only Per-protocol population subjects with abnormal liver attenuation at baseline subjected to follow-up after 12 weeks
To evaluate the recover fatty liver effect of Antroquinonol on patients who with fatty liver by Investigator
Outcome measures
| Measure |
Placebo
n=15 Participants
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
Antroquinonol 50 mg PO
n=13 Participants
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 100 mg PO
n=12 Participants
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 150 mg PO
n=11 Participants
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
|---|---|---|---|---|
|
Fatty Liver
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 8 deaths
Antroquinonol 50 mg PO
Serious events: 0 serious events
Other events: 8 other events
Deaths: 8 deaths
Antroquinonol 100 mg PO
Serious events: 1 serious events
Other events: 12 other events
Deaths: 12 deaths
Antroquinonol 150 mg PO
Serious events: 0 serious events
Other events: 17 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Placebo
n=14 participants at risk
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
Antroquinonol 50 mg PO
n=13 participants at risk
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 100 mg PO
n=19 participants at risk
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 150 mg PO
n=18 participants at risk
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
|---|---|---|---|---|
|
Renal and urinary disorders
ureterolithiasis and urinary tract disorder
|
0.00%
0/14 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
0.00%
0/13 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
5.3%
1/19 • Number of events 2 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
0.00%
0/18 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
Other adverse events
| Measure |
Placebo
n=14 participants at risk
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 (Placebo) 3 capsules once a day.
placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
|
Antroquinonol 50 mg PO
n=13 participants at risk
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 (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 100 mg PO
n=19 participants at risk
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 (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
Antroquinonol 150 mg PO
n=18 participants at risk
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 ) 3 capsules once a day.
Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
4/14 • Number of events 4 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
61.5%
8/13 • Number of events 8 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
47.4%
9/19 • Number of events 9 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
72.2%
13/18 • Number of events 13 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
0.00%
0/13 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
15.8%
3/19 • Number of events 3 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
16.7%
3/18 • Number of events 3 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
7.7%
1/13 • Number of events 1 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
0.00%
0/19 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
16.7%
3/18 • Number of events 3 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
14.3%
2/14 • Number of events 2 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
23.1%
3/13 • Number of events 3 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
0.00%
0/19 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
5.6%
1/18 • Number of events 1 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.3%
2/14 • Number of events 2 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
0.00%
0/13 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
0.00%
0/19 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
0.00%
0/18 • 16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
there are few patients had more than one AE during the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place