Trial Outcomes & Findings for Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients (NCT NCT05761444)
NCT ID: NCT05761444
Last Updated: 2025-09-09
Results Overview
Blood samples were collected to determine the LDL-C values. The percentage change from baseline was defined as 100 x (LDL-C value at 6 weeks - LDL-C value at baseline)/LDL-C value at baseline. Baseline was defined as the last non-missing measurement taken prior to reference start date.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
137 participants
Primary outcome timeframe
Baseline (Day 1) and Week 6
Results posted on
2025-09-09
Participant Flow
This Phase 4, open-label, active-controlled study was conducted in very high-risk dyslipidemia participants at 8 centers in South Korea between 26 July 2023 and 15 October 2024.
The study consisted of a screening period (1 week), an treatment period (12 weeks), and an end-of-study assessment (at Week 12). A total of 137 participants were randomized and enrolled in the study.
Participant milestones
| Measure |
Ezetimibe/Atorvastatin
Participants received ezetimibe/atorvastatin 10/40 milligram (mg) tablet orally once a day (QD) from Day 1 to Week 6.
If the low-density lipoprotein cholesterol (LDL-C) target was reached \<55 mg/deciliter (dL) at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
70
|
|
Overall Study
Treated
|
67
|
69
|
|
Overall Study
COMPLETED
|
59
|
65
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Ezetimibe/Atorvastatin
Participants received ezetimibe/atorvastatin 10/40 milligram (mg) tablet orally once a day (QD) from Day 1 to Week 6.
If the low-density lipoprotein cholesterol (LDL-C) target was reached \<55 mg/deciliter (dL) at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ezetimibe/Atorvastatin
n=67 Participants
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=69 Participants
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 10.07 • n=67 Participants
|
64.7 years
STANDARD_DEVIATION 10.66 • n=69 Participants
|
64.9 years
STANDARD_DEVIATION 10.34 • n=136 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=67 Participants
|
17 Participants
n=69 Participants
|
29 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=67 Participants
|
52 Participants
n=69 Participants
|
107 Participants
n=136 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
67 Participants
n=67 Participants
|
69 Participants
n=69 Participants
|
136 Participants
n=136 Participants
|
|
Low-Density Lipoprotein Cholesterol
|
98.1 mg/dL
STANDARD_DEVIATION 23.81 • n=67 Participants
|
107.8 mg/dL
STANDARD_DEVIATION 34.14 • n=69 Participants
|
103.0 mg/dL
STANDARD_DEVIATION 29.79 • n=136 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 6Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment and had a baseline assessment of LDL-C and at least 1 valid post baseline measurement of LDL-C.
Blood samples were collected to determine the LDL-C values. The percentage change from baseline was defined as 100 x (LDL-C value at 6 weeks - LDL-C value at baseline)/LDL-C value at baseline. Baseline was defined as the last non-missing measurement taken prior to reference start date.
Outcome measures
| Measure |
Ezetimibe/Atorvastatin
n=65 Participants
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=67 Participants
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6. If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6
|
-48.97 percentage change
Standard Error 2.71
|
-27.75 percentage change
Standard Error 2.47
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: The FAS included all randomized participants who received at least 1 dose of study treatment and had a baseline assessment of LDL-C and at least 1 valid post baseline measurement of LDL-C. Only participants with data collected at specific timepoints are reported.
Blood samples were collected to determine the LDL-C values. Participants with LDL-C \<55 mg/dL were identified. Percentages are rounded off to the hundredth decimal place.
Outcome measures
| Measure |
Ezetimibe/Atorvastatin
n=65 Participants
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=67 Participants
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6. If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12
Week 6
|
46.2 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12
Week 12
|
55.0 percentage of participants
|
15.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: The FAS included all randomized participants who received at least 1 dose of study treatment and had a baseline assessment of LDL-C and at least 1 valid post baseline measurement of LDL-C. Only participants with data collected at specific timepoints are reported.
Blood samples were collected to determine the LDL-C values. Participants with LDL-C \<70 mg/dL were identified. Percentages are rounded off to the hundredth decimal place.
Outcome measures
| Measure |
Ezetimibe/Atorvastatin
n=65 Participants
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=67 Participants
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6. If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12
Week 6
|
78.5 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12
Week 12
|
85.0 percentage of participants
|
58.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The FAS included all randomized participants who received at least 1 dose of study treatment and had a baseline assessment of LDL-C and at least 1 valid post baseline measurement of LDL-C. Only participants with data collected at baseline and Week 12 are reported.
Blood samples were collected to determine the LDL-C values. The percentage change from baseline was defined as 100 x (LDL-C value at 12 weeks - LDL-C value at baseline)/LDL-C value at baseline. Baseline was defined as the last non-missing measurement taken prior to reference start date.
Outcome measures
| Measure |
Ezetimibe/Atorvastatin
n=60 Participants
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=65 Participants
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6. If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12
|
-50.37 percentage change
Standard Error 2.60
|
-34.41 percentage change
Standard Error 2.32
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 6 and 12Population: The FAS included all randomized participants who received at least 1 dose of study treatment and had a baseline assessment of LDL-C and at least 1 valid post baseline measurement of LDL-C. Only participants with data collected at specific timepoints are reported.
Blood samples were collected to determine the HDL-C, non-HDL-C, triglycerides, and total cholesterol values. The percentage change from baseline for HDL-C was defined as 100 x (HDL-C value at 6 or 12 weeks - HDL-C value at baseline)/HDL-C value at baseline. The percentage change from baseline for non-HDL-C was defined as 100 x (non-HDL-C value at 6 or 12 weeks - non-HDL-C value at baseline)/non-HDL-C value at baseline. The percentage change from baseline for triglycerides was defined as 100 x (triglycerides value at 6 or 12 weeks - triglycerides value at baseline)/triglycerides value at baseline. The percentage change from baseline for total cholesterol was defined as 100 x (total cholesterol value at 6 or 12 weeks - total cholesterol value at baseline)/total cholesterol value at baseline. Baseline was defined as the last non-missing measurement taken prior to reference start date.
Outcome measures
| Measure |
Ezetimibe/Atorvastatin
n=65 Participants
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=67 Participants
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6. If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12
Week 6: HDL-C
|
-2.44 percentage change
Standard Deviation 17.837
|
-0.18 percentage change
Standard Deviation 17.479
|
|
Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12
Week 12: HDL-C
|
-2.15 percentage change
Standard Deviation 18.964
|
-1.47 percentage change
Standard Deviation 17.163
|
|
Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12
Week 6: non-HDL-C
|
-35.36 percentage change
Standard Deviation 18.378
|
-24.36 percentage change
Standard Deviation 21.625
|
|
Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12
Week 12: non-HDL-C
|
-39.97 percentage change
Standard Deviation 15.558
|
-29.48 percentage change
Standard Deviation 18.422
|
|
Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12
Week 6: Triglycerides
|
-9.67 percentage change
Standard Deviation 40.806
|
-4.94 percentage change
Standard Deviation 59.649
|
|
Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12
Week 12: Triglycerides
|
-16.67 percentage change
Standard Deviation 31.948
|
-1.49 percentage change
Standard Deviation 65.605
|
|
Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12
Week 6: Total cholesterol
|
-26.28 percentage change
Standard Deviation 14.692
|
-18.51 percentage change
Standard Deviation 15.754
|
|
Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12
Week 12: Total cholesterol
|
-29.57 percentage change
Standard Deviation 13.563
|
-22.18 percentage change
Standard Deviation 13.722
|
SECONDARY outcome
Timeframe: From the first dose administration of the study treatment (Day 1) up to Week 6; From the first dose administration of the study treatment (Day 1) up to Week 12Population: The SAS included all randomized participants who received at least 1 dose of study treatment.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A TEAE was defined as AEs that first occurred or worsened in severity on or after the first administration of the study treatment during the treatment period.
Outcome measures
| Measure |
Ezetimibe/Atorvastatin
n=67 Participants
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=69 Participants
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6. If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12
Week 12: Any TEAE
|
15 Participants
|
13 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12
Week 6: Any TEAE
|
9 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12
Week 6: Any TESAE
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12
Week 12: Any TESAE
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the first dose administration of the study treatment (Day 1) up to Week 6; From the first dose administration of the study treatment (Day 1) up to Week 12Population: The SAS included all randomized participants who received at least 1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A TEAE was defined as AEs that first occurred or worsened in severity on or after the first administration of the study treatment during the treatment period.
Outcome measures
| Measure |
Ezetimibe/Atorvastatin
n=67 Participants
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=69 Participants
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6. If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study
Week 6
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study
Week 12
|
3 Participants
|
2 Participants
|
Adverse Events
Ezetimibe/Atorvastatin
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Atorvastatin
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe/Atorvastatin
n=67 participants at risk
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=69 participants at risk
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Melaena
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest discomfort
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
2/67 • Number of events 2 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
3.0%
2/67 • Number of events 2 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/67 • Number of events 2 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Ezetimibe/Atorvastatin
n=67 participants at risk
Participants received ezetimibe/atorvastatin 10/40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to ezetimibe/atorvastatin 10/80 mg QD from Week 6 to Week 12.
|
Atorvastatin
n=69 participants at risk
Participants received atorvastatin 40 mg tablet orally QD from Day 1 to Week 6.
If the LDL-C target was reached \<55 mg/dL at Week 6, the dose was maintained up to Week 12. If the LDL-C target was not reached at Week 6, dose was increased to atorvastatin 80 mg QD from Week 6 to Week 12.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest discomfort
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
AST/ALT ratio abnormal
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 3 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/67 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/67 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • TEAEs are reported from the first dose administration of the study treatment (Day 1) up to end of the study, 12 weeks.
The SAS included all randomized participants who received at least 1 dose of study treatment.
|
Additional Information
Clinical Lead, Late-Stage Clinical Development
Organon Korea Co. Ltd
Phone: 551-430-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place