Trial Outcomes & Findings for A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia (NCT NCT04784442)
NCT ID: NCT04784442
Last Updated: 2024-05-10
Results Overview
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Day 1. When LDL-C at Week 12 was missing, the missing value was imputed using the last observation carried forward from the start of the IMP administration to 2 days after the final IMP administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
188 participants
Primary outcome timeframe
Baseline, week12
Results posted on
2024-05-10
Participant Flow
Participant milestones
| Measure |
ETC-1002 60 mg
ETC-1002 60 mg tablet once daily for 12 weeks.
|
ETC-1002 120 mg
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
Placebo tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
48
|
47
|
|
Overall Study
COMPLETED
|
44
|
46
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
ETC-1002 60 mg
ETC-1002 60 mg tablet once daily for 12 weeks.
|
ETC-1002 120 mg
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
Placebo tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Non-compliance with study drug
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 9.26 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 8.94 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 10.65 • n=4 Participants
|
61.2 years
STANDARD_DEVIATION 10.28 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
45 participants
n=5 Participants
|
46 participants
n=7 Participants
|
48 participants
n=5 Participants
|
47 participants
n=4 Participants
|
186 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, week12Population: The FAS included all subjects who receive at least one dose of IMP during the treatment period and for whom LDL-C values at baseline and at least one post-dose (up to 2 days after final IMP administration) are observed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Day 1. When LDL-C at Week 12 was missing, the missing value was imputed using the last observation carried forward from the start of the IMP administration to 2 days after the final IMP administration.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in LDL-C From Baseline to Week 12
|
-21.85 Percent Change
Standard Error 2.156
|
-21.26 Percent Change
Standard Error 2.095
|
-1.92 Percent Change
Standard Error 2.117
|
-10.59 Percent Change
Standard Error 2.153
|
SECONDARY outcome
Timeframe: Baseline, week12Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in HDL Cholesterol From Baseline to Week 12
|
-0.65 Percent Change
Standard Error 2.190
|
-7.29 Percent Change
Standard Error 2.139
|
3.08 Percent Change
Standard Error 2.155
|
0.16 Percent Change
Standard Error 2.208
|
SECONDARY outcome
Timeframe: Baseline, week12Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in Non-HDL Cholesterol From Baseline to Week 12
|
-18.29 Percent Change
Standard Error 2.021
|
-16.01 Percent Change
Standard Error 1.956
|
-1.62 Percent Change
Standard Error 1.988
|
-8.86 Percent Change
Standard Error 2.019
|
SECONDARY outcome
Timeframe: Baseline, week12Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in Total Cholesterol From Baseline to Week 12
|
-13.61 Percent Change
Standard Error 1.650
|
-13.56 Percent Change
Standard Error 1.599
|
-0.55 Percent Change
Standard Error 1.621
|
-6.42 Percent Change
Standard Error 1.665
|
SECONDARY outcome
Timeframe: Baseline, week12Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=46 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in Triglycerides From Baseline to Week 12
|
-5.62 Percent Change
Standard Error 6.290
|
9.17 Percent Change
Standard Error 6.151
|
-0.08 Percent Change
Standard Error 6.219
|
-9.09 Percent Change
Standard Error 6.286
|
SECONDARY outcome
Timeframe: Baseline, week12Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=46 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in Apolipoprotein B From Baseline to Week 12
|
-14.59 Percent Change
Standard Error 1.709
|
-12.47 Percent Change
Standard Error 1.704
|
-2.13 Percent Change
Standard Error 1.704
|
-8.18 Percent Change
Standard Error 1.715
|
SECONDARY outcome
Timeframe: Baseline, week12Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=46 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12
|
1.02 Percent Change
Standard Error 62.418
|
-34.58 Percent Change
Standard Error 62.745
|
0.98 Percent Change
Standard Error 61.513
|
150.54 Percent Change
Standard Error 62.494
|
SECONDARY outcome
Timeframe: Baseline, week12Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=46 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in Hemoglobin A1c From Baseline to Week 12
|
-0.40 Percent Change
Standard Error 0.596
|
-0.21 Percent Change
Standard Error 0.592
|
-0.05 Percent Change
Standard Error 0.578
|
0.11 Percent Change
Standard Error 0.591
|
SECONDARY outcome
Timeframe: Baseline, week12The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 12.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12
|
26 participants
|
28 participants
|
1 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Baseline, week12The proportion of subjects whose LDL-C value achieves \<70 mg/dL at Week 12.
Outcome measures
| Measure |
ETC-1002 120 mg
n=46 Participants
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 Participants
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet once daily for 12 weeks.
|
ETC-1002 60 mg
n=45 Participants
ETC-1002 60 mg tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Proportion of Subjects Whose LDL-C Value Achieve < 70 mg/dL at Week 12
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
ETC-1002 60 mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
ETC-1002 120 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
ETC-1002 180 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ETC-1002 60 mg
n=47 participants at risk
ETC-1002 60 mg tablet once daily for 12 weeks.
|
ETC-1002 120 mg
n=46 participants at risk
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 participants at risk；n=47 participants at risk
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 participants at risk；n=48 participants at risk
Placebo tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
Other adverse events
| Measure |
ETC-1002 60 mg
n=47 participants at risk
ETC-1002 60 mg tablet once daily for 12 weeks.
|
ETC-1002 120 mg
n=46 participants at risk
ETC-1002 120 mg tablet once daily for 12 weeks.
|
ETC-1002 180 mg
n=48 participants at risk；n=47 participants at risk
ETC-1002 180 mg tablet once daily for 12 weeks.
|
Placebo
n=47 participants at risk；n=48 participants at risk
Placebo tablet once daily for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
4/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.2%
1/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
3/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.2%
1/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
General disorders
Fatigue
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.2%
1/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
General disorders
Malaise
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.5%
3/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.2%
3/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
General disorders
Pyrexia
|
10.6%
5/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
8.7%
4/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
General disorders
Vaccination site pain
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.5%
3/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
General disorders
Vaccination site swelling
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
10.4%
5/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.2%
1/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.2%
2/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.2%
3/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.2%
2/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.2%
1/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.2%
2/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.2%
2/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Investigations
Blood uric acid increased
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.5%
3/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.1%
1/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.2%
3/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
3/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.2%
2/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
2.2%
1/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.2%
3/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.4%
3/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Nervous system disorders
Headache
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
10.9%
5/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.2%
2/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.1%
1/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
0.00%
0/46 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
6.2%
3/48 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
4.3%
2/47 • Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., Ltd.
Phone: +81363617366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place