Clinical Trials List
Protocol NumberB1481022
2013-12-01 - 2019-12-31
Phase III
Terminated10
ICD-10NoDx
0
ICD-9E942.2
Antilipaemic and antiarteriosclerotic drugs causing adverse effects in therapeutic use
Phase 3 Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Pf-04950615, In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
-
Sponsor
Pfizer Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- Wen-Chung Yu Division of Cardiovascular Diseases
- 林幸榮 Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
- Kang-Ling Wang Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 蔡瑞鵬 Division of Cardiovascular Diseases
- 藍偉仁 Division of Cardiovascular Diseases
- 劉俊傑 Division of Cardiovascular Diseases
- 余法昌 Division of Cardiovascular Diseases
- 林岳鴻 Division of Cardiovascular Diseases
- 張盛雄 Division of Cardiovascular Diseases
- 蔡政廷 Division of Cardiovascular Diseases
- 顏志軒 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Cheng-Han Lee Division of Cardiovascular Diseases
- Ping-Yen Liu Division of Cardiovascular Diseases
- 李貽恆 Division of Cardiovascular Diseases
- Ting-Hsing Chao Division of Cardiovascular Diseases
- Yi-Heng Li Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 謝禮全 Division of Cardiovascular Diseases
- 林晏年 Division of Cardiovascular Diseases
- 吳宏彬 Division of Cardiovascular Diseases
- Po-Yen Ko Division of Cardiovascular Diseases
- 陳恬恩 Division of Cardiovascular Diseases
- 張志斌 Division of Cardiovascular Diseases
- 陳業鵬 Division of Cardiovascular Diseases
- Lien-Cheng Hsiao Division of Cardiovascular Diseases
- Shih-Sheng Chang Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- Pei-Ying Pai Division of Cardiovascular Diseases
- 盧炯睿 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- 林岳鴻 Division of Cardiovascular Diseases
- 張盛雄 Division of Cardiovascular Diseases
- 蔡瑞鵬 Division of Cardiovascular Diseases
- 藍偉仁 Division of Cardiovascular Diseases
- 蔡政廷 Division of Cardiovascular Diseases
- 顏志軒 Division of Cardiovascular Diseases
- 劉俊傑 Division of Cardiovascular Diseases
- 余法昌 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Major Cardiovascular Events
Objectives
The time from randomization to the first adjudicated and confirmed occurrence of a major
cardiovascular event, a composite endpoint that includes CV death, non-fatal MI, non-fatal
stroke, and hospitalization for unstable angina needing urgent revascularization
Test Drug
PF-04950615
Active Ingredient
PF-04950615
Dosage Form
針劑
Dosage
100 mg/mL
Endpoints
Primary Endpoint
The time from randomization to the first adjudicated and confirmed occurrence of a major
cardiovascular event, a composite endpoint that includes CV death, non-fatal MI, non-fatal
stroke, and hospitalization for unstable angina needing urgent revascularization.
Key Secondary Endpoints
The times from randomization to the first adjudicated and confirmed occurrence of the
following endpoints :
Hospitalization for unstable angina needing urgent revascularization;
A composite endpoint of CV death, non-fatal MI, and non-fatal stroke;
A composite endpoint of all-cause death, non-fatal MI, non-fatal stroke, and
hospitalization for unstable angina needing urgent revascularization
The time from randomization to the first adjudicated and confirmed occurrence of a major
cardiovascular event, a composite endpoint that includes CV death, non-fatal MI, non-fatal
stroke, and hospitalization for unstable angina needing urgent revascularization.
Key Secondary Endpoints
The times from randomization to the first adjudicated and confirmed occurrence of the
following endpoints :
Hospitalization for unstable angina needing urgent revascularization;
A composite endpoint of CV death, non-fatal MI, and non-fatal stroke;
A composite endpoint of all-cause death, non-fatal MI, non-fatal stroke, and
hospitalization for unstable angina needing urgent revascularization
Inclution Criteria
Subject eligibility should be reviewed and documented by an appropriately qualified member
of the investigator’s study team (Section 4.5) before subjects are included in the study.
A key element of eligibility is the investigator’s documentation that the subject is at high or
very high risk of incurring a CV event. Adequate documentation of objective evidence of the
criterion that qualifies the subject as being at high risk or very high risk for CVD events must
be available in the investigational site’s source documents including medical records, copies
of such records from other institutions, or a letter from a referring physician that specifically
provides diagnostic information and/or diagnosis and date of a qualifying CV event, when
relevant.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
study, with the one exception, that for CV risk factors, subjects may be eligible for
recruitment if they have had a prior CVD event, as described in criterion 6, or if they have a
CVD risk equivalent with two additional risk factors, as described in criterion 7:
1. Evidence of a personally signed and dated informed consent document indicating that the
subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and
other study procedures.
3. Age: men or women aged 18 years for those with a confirmed prior CVD event
(Section 4.1 #6); or men aged ≥ 55 years, or women, aged ≥ 65 years with a CVD risk
equivalent (Section 4.1 #7).
4. Willing and able to self-administer or be administered sub-cutaneous injections of
investigational product.
5. Must be treated with atorvastatin, rosuvastatin, or simvastatin, at the highest locally
approved dose. If at a lower dose, there must be documentation that the subject is
receiving a maximally tolerated dose of the aforementioned statins, or that the subject is
at his or her LDL-C or non-HDL-C target; and no dose should be lower than atorvastatin
20 mg, rosuvastatin 20 mg, or simvastatin 40 mg, once a day.
Subjects on simvastatin 80 mg must have been on this dose for > 1 year before
screening.
All subjects must be on a stable dose at least 6 weeks prior to screening. There
should be no plans at the time of screening and randomization to modify the dose of
statin for the duration of the trial.
Source records and case report form (CRF) documentation of the above, must be
shown.
6. Qualifying CV risk factor: prior CVD event.
A prior CVD event must be documented by source documentation that includes an
anonymized hospital discharge summary describing the qualifying index CVD event
diagnosis or surgical event and that includes documentation of the event’s date of
occurrence.
Qualifying prior CVD event:
a. greater than thirty days but no more than five years post prior myocardial infarction
as defined by the universal definition of MI (excluding those with MI due to cocaine
abuse or vasospasm) or ischemic stroke, as documented by hospital discharge
summary and brain imaging scan
b. greater than one year but no more than five years post previous cardiac
revascularization including PCI or CABG, as documented by hospital discharge
summary
c. pre- existing arterial revascularization, documented as a carotid, or peripheral artery
revascularization, as defined as surgery or stent placement and documented by
hospital discharge summary (at least one month [30 days] but no more than five years
prior to screening)
7. Qualifying CV risk factor: CVD risk equivalent with two additional risk factors:
Type I or Type II diabetes mellitus, as defined per local diabetes guidelines (eg,
American Diabetes Association [ADA] in the U.S.A, European Association for the
Study of Diabetes [EASD] in the European Union [E.U.]) heterozygous familial
hypercholesterolemia (heFH)(as defined in Appendix 2), subjects with symptomatic
peripheral vascular disease (as defined in Appendix 3) or chronic kidney disease
(with a glomerular filtration rate of 30 and 60 mL/min/1.73m2, based on the
screening visit measurement of creatinine, as calculated by Modification of Diet in
Renal Disease [MDRD] formula, and not on dialysis) and 55 years of age for men
and 65 years of age for women, with at least two of the following additional risk
factors for CVD:
a. Evidence of coronary artery stenoses of > 50% narrowing in at least two major
coronary arteries as documented by coronary arteryb. Current cigarette smoking, defined as smoking for 30 days or more (any number of
cigarettes) at the time of screening;
c. HDL-C < 40 mg/dL (< 1.0 mmol/L) as measured at the screening visit;
d. hs-CRP > 2.0 mg/L documented within one year of the screening visit;
e. A glomerular filtration rate (GFR) 30 and 60 mL/min/1.73m2 (based on the
creatinine measured at the screening visit, and as calculated by the MDRD formula).
8. Subject must have an LDL-C 70 mg/dL (1.8 mmol/L) and < 100 mg/dL (2.6 mmol/L)
or non-HDL-C 100 mg/dL (2.6 mmol/L) and < 130 mg/dL (3.4 mmol/L) at Visit 3.
9. Male and female subjects of childbearing potential must agree to use a highly effective
method of contraception throughout the study and for at least 63 days after the last dose
of assigned treatment. A subject is of childbearing potential if, in the opinion of the
investigator, he/she is biologically capable of having children and is sexually active.
10. Female subjects who are not of childbearing potential should meet at least one of the
following criteria:
a. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
b. Have medically confirmed ovarian failure, or
c. Achieved post-menopausal status, defined as: cessation of regular menses for at
least 12 consecutive months with no alternative pathological or physiological
cause; and have a serum follicle stimulating hormone (FSH) level within the
laboratory’s reference range for postmenopausal females. imaging;
of the investigator’s study team (Section 4.5) before subjects are included in the study.
A key element of eligibility is the investigator’s documentation that the subject is at high or
very high risk of incurring a CV event. Adequate documentation of objective evidence of the
criterion that qualifies the subject as being at high risk or very high risk for CVD events must
be available in the investigational site’s source documents including medical records, copies
of such records from other institutions, or a letter from a referring physician that specifically
provides diagnostic information and/or diagnosis and date of a qualifying CV event, when
relevant.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
study, with the one exception, that for CV risk factors, subjects may be eligible for
recruitment if they have had a prior CVD event, as described in criterion 6, or if they have a
CVD risk equivalent with two additional risk factors, as described in criterion 7:
1. Evidence of a personally signed and dated informed consent document indicating that the
subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and
other study procedures.
3. Age: men or women aged 18 years for those with a confirmed prior CVD event
(Section 4.1 #6); or men aged ≥ 55 years, or women, aged ≥ 65 years with a CVD risk
equivalent (Section 4.1 #7).
4. Willing and able to self-administer or be administered sub-cutaneous injections of
investigational product.
5. Must be treated with atorvastatin, rosuvastatin, or simvastatin, at the highest locally
approved dose. If at a lower dose, there must be documentation that the subject is
receiving a maximally tolerated dose of the aforementioned statins, or that the subject is
at his or her LDL-C or non-HDL-C target; and no dose should be lower than atorvastatin
20 mg, rosuvastatin 20 mg, or simvastatin 40 mg, once a day.
Subjects on simvastatin 80 mg must have been on this dose for > 1 year before
screening.
All subjects must be on a stable dose at least 6 weeks prior to screening. There
should be no plans at the time of screening and randomization to modify the dose of
statin for the duration of the trial.
Source records and case report form (CRF) documentation of the above, must be
shown.
6. Qualifying CV risk factor: prior CVD event.
A prior CVD event must be documented by source documentation that includes an
anonymized hospital discharge summary describing the qualifying index CVD event
diagnosis or surgical event and that includes documentation of the event’s date of
occurrence.
Qualifying prior CVD event:
a. greater than thirty days but no more than five years post prior myocardial infarction
as defined by the universal definition of MI (excluding those with MI due to cocaine
abuse or vasospasm) or ischemic stroke, as documented by hospital discharge
summary and brain imaging scan
b. greater than one year but no more than five years post previous cardiac
revascularization including PCI or CABG, as documented by hospital discharge
summary
c. pre- existing arterial revascularization, documented as a carotid, or peripheral artery
revascularization, as defined as surgery or stent placement and documented by
hospital discharge summary (at least one month [30 days] but no more than five years
prior to screening)
7. Qualifying CV risk factor: CVD risk equivalent with two additional risk factors:
Type I or Type II diabetes mellitus, as defined per local diabetes guidelines (eg,
American Diabetes Association [ADA] in the U.S.A, European Association for the
Study of Diabetes [EASD] in the European Union [E.U.]) heterozygous familial
hypercholesterolemia (heFH)(as defined in Appendix 2), subjects with symptomatic
peripheral vascular disease (as defined in Appendix 3) or chronic kidney disease
(with a glomerular filtration rate of 30 and 60 mL/min/1.73m2, based on the
screening visit measurement of creatinine, as calculated by Modification of Diet in
Renal Disease [MDRD] formula, and not on dialysis) and 55 years of age for men
and 65 years of age for women, with at least two of the following additional risk
factors for CVD:
a. Evidence of coronary artery stenoses of > 50% narrowing in at least two major
coronary arteries as documented by coronary arteryb. Current cigarette smoking, defined as smoking for 30 days or more (any number of
cigarettes) at the time of screening;
c. HDL-C < 40 mg/dL (< 1.0 mmol/L) as measured at the screening visit;
d. hs-CRP > 2.0 mg/L documented within one year of the screening visit;
e. A glomerular filtration rate (GFR) 30 and 60 mL/min/1.73m2 (based on the
creatinine measured at the screening visit, and as calculated by the MDRD formula).
8. Subject must have an LDL-C 70 mg/dL (1.8 mmol/L) and < 100 mg/dL (2.6 mmol/L)
or non-HDL-C 100 mg/dL (2.6 mmol/L) and < 130 mg/dL (3.4 mmol/L) at Visit 3.
9. Male and female subjects of childbearing potential must agree to use a highly effective
method of contraception throughout the study and for at least 63 days after the last dose
of assigned treatment. A subject is of childbearing potential if, in the opinion of the
investigator, he/she is biologically capable of having children and is sexually active.
10. Female subjects who are not of childbearing potential should meet at least one of the
following criteria:
a. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
b. Have medically confirmed ovarian failure, or
c. Achieved post-menopausal status, defined as: cessation of regular menses for at
least 12 consecutive months with no alternative pathological or physiological
cause; and have a serum follicle stimulating hormone (FSH) level within the
laboratory’s reference range for postmenopausal females. imaging;
Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
1. Subjects who are investigational site staff members directly involved in the conduct of
the trial and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of the
trial.
2. A planned coronary (PCI or CABG) or other arterial revascularization.
3. Participation in other studies involving molecule investigational drug(s) (Phases 1-4)
within 1 month, any participation in a cholesteryl ester transfer protein (CETP) inhibitor
trial for any length of time, or biological agents within 6 months or 5 half lives,
whichever is longer before the current study begins and/or during study participation (the
investigator should refer to documents provided by the subject on the other study to
determine the investigational product half life). If the blind has been broken and the
investigator knows (with documentation) that the subject received placebo, he/she can be
included.
4. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
5. Pregnant females; breastfeeding females; males and females of childbearing potential
who are unwilling or unable to use a highly effective method of contraception as outlined
in this protocol for the duration of the study and for 63 days after last dose of
investigational product (refer to Section 4.4.2).
6. Latex sensitive individuals (due to potential for exposure to natural dry rubber in the prefilled
syringe cap of investigational product, during administration).
7. Potential subjects with an LDL-C < 70 mg/dL (< 1.8 mmol/L) or 100 mg/dL (2.6
mmol/L or non-HDL-C < 100 mg/dL (2.6 mmol/L) or 130 mg/dL (3.4 mmol/L) at Visit
1 or Visit 3.
8. Undergoing lipid apheresis or planned start of lipid apheresis.
9. Congestive heart failure of New York Heart Association (NYHA) Class IV, or left
ventricular ejection fraction (LVEF) of < 25%, measured by imaging.
10. Potential subjects with end stage renal disease on dialysis.
11. Potential subjects with chronic renal insufficiency and a creatinine clearance of
< 30 ml/min/1.73m2 by MDRD formula.
12. Poorly controlled hypertension (defined as the average of two systolic blood pressure
(BP) measurements greater than 160 mm Hg or diastolic BP measurements greater than
100 mm Hg, even with treatment). Subjects who have hypertension and are controlled on
stable dosages of anti hypertensive medications can be included. Subjects may be
permitted into the study if in the Principal Investigator’s opinion the assessment(s) are
not clinically significant. BP measurement may be repeated up to three times within the
hour or at the completion of the office visit, to confirm a reading.
11. A prior history of hemorrhagic stroke.
12. Plans to donate blood during the study.
13. Current history of alcoholism or drug addiction according to diagnostic and statistical
manual of mental disorders (DSM) IV criteria within 12 months prior to screening. Use
of any recreational drugs within 12 months prior to screening.
14. Medical history of positive testing for human immunodeficiency virus (HIV).
15. Subjects with prior exposure to PF-04950615 (RN316) or other investigational PCSK9
inhibitor.
16. Subjects who are receiving routine intramuscular (IM) injections or for whom IM therapy
is anticipated during the course of the study. Elevations of Creatinine Kinase (CK) is
known to occur with IM injections, hence the elimination of the use of IM injections with
concomitant medications will minimize the diagnostic uncertainty of CK elevations.
17. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal
antibody (immunoglobulin G (IgG) protein) or molecules made of components of
monoclonal antibodies (eg, Enbrel® which contains the fragment crystallizable (Fc)
portion of an antibody or Lucentis® which is a monoclonal antibody fragment).
18. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or
hepatitis C antibody tests indicative of present or prior infection. NOTE: If a subject tests
negative for HBsAg, but positive for HBcAb, the subject would be considered eligible if
the subject tests positive for antibody to HB surface antigen (HBsAb or anti HBsAg)
reflex testing.
19. Creatinine kinase (CK) > 3.0 x upper limit of normal (ULN). A measurement > 3.0 x
ULN may be repeated once during screening, and if <3.0 xULN the subject is eligible.
20. Alanine amino transferase (ALT) or aspartate amino transferase (AST) > 2 x ULN.
21. Direct bilirubin > 1.5 x ULN.
22. Subjects with cancer who are actively receiving chemotherapy. Potential subjects with a
prior history of malignancy should have thorough documentation of the malignancy type
and the extent of disease. Potential subjects considered at high risk of recurrence or the
development of metastatic disease within the time frame of the conduct of the clinical
trial should be excluded.
1. Subjects who are investigational site staff members directly involved in the conduct of
the trial and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of the
trial.
2. A planned coronary (PCI or CABG) or other arterial revascularization.
3. Participation in other studies involving molecule investigational drug(s) (Phases 1-4)
within 1 month, any participation in a cholesteryl ester transfer protein (CETP) inhibitor
trial for any length of time, or biological agents within 6 months or 5 half lives,
whichever is longer before the current study begins and/or during study participation (the
investigator should refer to documents provided by the subject on the other study to
determine the investigational product half life). If the blind has been broken and the
investigator knows (with documentation) that the subject received placebo, he/she can be
included.
4. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
5. Pregnant females; breastfeeding females; males and females of childbearing potential
who are unwilling or unable to use a highly effective method of contraception as outlined
in this protocol for the duration of the study and for 63 days after last dose of
investigational product (refer to Section 4.4.2).
6. Latex sensitive individuals (due to potential for exposure to natural dry rubber in the prefilled
syringe cap of investigational product, during administration).
7. Potential subjects with an LDL-C < 70 mg/dL (< 1.8 mmol/L) or 100 mg/dL (2.6
mmol/L or non-HDL-C < 100 mg/dL (2.6 mmol/L) or 130 mg/dL (3.4 mmol/L) at Visit
1 or Visit 3.
8. Undergoing lipid apheresis or planned start of lipid apheresis.
9. Congestive heart failure of New York Heart Association (NYHA) Class IV, or left
ventricular ejection fraction (LVEF) of < 25%, measured by imaging.
10. Potential subjects with end stage renal disease on dialysis.
11. Potential subjects with chronic renal insufficiency and a creatinine clearance of
< 30 ml/min/1.73m2 by MDRD formula.
12. Poorly controlled hypertension (defined as the average of two systolic blood pressure
(BP) measurements greater than 160 mm Hg or diastolic BP measurements greater than
100 mm Hg, even with treatment). Subjects who have hypertension and are controlled on
stable dosages of anti hypertensive medications can be included. Subjects may be
permitted into the study if in the Principal Investigator’s opinion the assessment(s) are
not clinically significant. BP measurement may be repeated up to three times within the
hour or at the completion of the office visit, to confirm a reading.
11. A prior history of hemorrhagic stroke.
12. Plans to donate blood during the study.
13. Current history of alcoholism or drug addiction according to diagnostic and statistical
manual of mental disorders (DSM) IV criteria within 12 months prior to screening. Use
of any recreational drugs within 12 months prior to screening.
14. Medical history of positive testing for human immunodeficiency virus (HIV).
15. Subjects with prior exposure to PF-04950615 (RN316) or other investigational PCSK9
inhibitor.
16. Subjects who are receiving routine intramuscular (IM) injections or for whom IM therapy
is anticipated during the course of the study. Elevations of Creatinine Kinase (CK) is
known to occur with IM injections, hence the elimination of the use of IM injections with
concomitant medications will minimize the diagnostic uncertainty of CK elevations.
17. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal
antibody (immunoglobulin G (IgG) protein) or molecules made of components of
monoclonal antibodies (eg, Enbrel® which contains the fragment crystallizable (Fc)
portion of an antibody or Lucentis® which is a monoclonal antibody fragment).
18. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or
hepatitis C antibody tests indicative of present or prior infection. NOTE: If a subject tests
negative for HBsAg, but positive for HBcAb, the subject would be considered eligible if
the subject tests positive for antibody to HB surface antigen (HBsAb or anti HBsAg)
reflex testing.
19. Creatinine kinase (CK) > 3.0 x upper limit of normal (ULN). A measurement > 3.0 x
ULN may be repeated once during screening, and if <3.0 xULN the subject is eligible.
20. Alanine amino transferase (ALT) or aspartate amino transferase (AST) > 2 x ULN.
21. Direct bilirubin > 1.5 x ULN.
22. Subjects with cancer who are actively receiving chemotherapy. Potential subjects with a
prior history of malignancy should have thorough documentation of the malignancy type
and the extent of disease. Potential subjects considered at high risk of recurrence or the
development of metastatic disease within the time frame of the conduct of the clinical
trial should be excluded.
The Estimated Number of Participants
-
Taiwan
175 participants
-
Global
12000 participants
