Atherosclerotic Cardiovascular Disease
Conditions
Keywords
Very high-risk patients' Atherosclerotic cardiovascular disease (ASCVD)
Brief summary
This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients. We intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.
Interventions
DRUGAtozet 10/40 mg or 10/80 mg
Atozet 10/40 mg or 10/80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily
DRUGLipitor 40 mg or 80 mg
Lipitor 40 mg or 80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily
Sponsors
Iqvia Pty Ltd
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are ≥ 30 years old. 2. Patients with very high-risk\*: clinical or unequivocal on imaging ASCVD. ASCVD includes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transient ischaemic attack (TIA), and peripheral arterial disease (Mach F 2020). 3. Patients (a) who failed to achieve their target LDL-C goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment * rosuvastatin \< 10 mg, atorvastatin \< 40 mg, and all dose of pitavastatin, simvastatin, lovastatin, pravastatin, and fluvastatin (Team G 2020). 4. Patients with LDL-C levels ≥ 70 mg/dL 5. Patients who are willing to maintain TLC throughout the study. 6. Patients who are willing to provide written informed consent prior to study enrollment.
Exclusion criteria
1. Patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactive ingredients. 2. Patients with active liver disease or unexplained persistent elevations of hepatic transaminase levels. (aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 x upper limit of normal (ULN)). 3. Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease. 4. Patients with myasthenia gravis. 5. Female patients who are pregnant or have a potential to be pregnant and nursing. 6. Patients who are taking glecaprevir and pibrentasvir. 7. Patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption. 8. Patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia. 9. Patients with a history of cancer within 5 years. 10. Patients whose life expectancy is less than 6 months due to their medical conditions. 11. Patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study. 12. Patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period. 13. Patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6 | Baseline (Day 1) and Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12 | Weeks 6 and 12 | 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. |
| Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12 | Baseline (Day 1) and Week 12 | 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. |
| Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12 | Weeks 6 and 12 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12 | 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 12 | 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. |
| Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study | 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 12 | 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. |
| 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 | Baseline (Day 1) and Weeks 6 and 12 | 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. |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Ezetimibe/Atorvastatin 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. | 67 |
| 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. | 69 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Ezetimibe/Atorvastatin | Atorvastatin | Total |
|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 10.07 | 64.7 years STANDARD_DEVIATION 10.66 | 64.9 years STANDARD_DEVIATION 10.34 |
| Low-Density Lipoprotein Cholesterol | 98.1 mg/dL STANDARD_DEVIATION 23.81 | 107.8 mg/dL STANDARD_DEVIATION 34.14 | 103.0 mg/dL STANDARD_DEVIATION 29.79 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 67 Participants | 69 Participants | 136 Participants |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 29 Participants |
| Sex: Female, Male Male | 55 Participants | 52 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 69 |
| other Total, other adverse events | 12 / 67 | 11 / 69 |
| serious Total, serious adverse events | 4 / 67 | 3 / 69 |
Outcome results
Primary
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6
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.
Time frame: Baseline (Day 1) and Week 6
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe/Atorvastatin | Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6 | -48.97 percentage change | Standard Error 2.71 |
| Atorvastatin | Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6 | -27.75 percentage change | Standard Error 2.47 |
p-value: <0.000195% CI: [-29.26, -13.19]ANCOVA
Secondary
Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study
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.
Time frame: 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 12
Population: The SAS included all randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ezetimibe/Atorvastatin | Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study | Week 6 | 2 Participants |
| Ezetimibe/Atorvastatin | Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study | Week 12 | 3 Participants |
| Atorvastatin | Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study | Week 6 | 2 Participants |
| Atorvastatin | Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study | Week 12 | 2 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12
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.
Time frame: 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 12
Population: The SAS included all randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Atorvastatin | 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 | 3 Participants |
| Atorvastatin | 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 | 8 Participants |
| Atorvastatin | 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 | 13 Participants |
| Atorvastatin | 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 | 2 Participants |
Secondary
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
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.
Time frame: Baseline (Day 1) and Weeks 6 and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Atorvastatin | 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 | -22.18 percentage change | Standard Deviation 13.722 |
| Atorvastatin | 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 | -0.18 percentage change | Standard Deviation 17.479 |
| Atorvastatin | 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 | -4.94 percentage change | Standard Deviation 59.649 |
| Atorvastatin | 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 | -1.47 percentage change | Standard Deviation 17.163 |
| Atorvastatin | 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 | -18.51 percentage change | Standard Deviation 15.754 |
| Atorvastatin | 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 | -24.36 percentage change | Standard Deviation 21.625 |
| Atorvastatin | 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 | -1.49 percentage change | Standard Deviation 65.605 |
| Atorvastatin | 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 | -29.48 percentage change | Standard Deviation 18.422 |
Secondary
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12
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.
Time frame: Baseline (Day 1) and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe/Atorvastatin | Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12 | -50.37 percentage change | Standard Error 2.6 |
| Atorvastatin | Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12 | -34.41 percentage change | Standard Error 2.32 |
p-value: <0.000195% CI: [-23.56, -8.36]ANCOVA
Secondary
Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12
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.
Time frame: Weeks 6 and 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Atorvastatin | Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12 | Week 6 | 9.0 percentage of participants |
| Atorvastatin | Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12 | Week 12 | 15.4 percentage of participants |
Secondary
Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12
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.
Time frame: Weeks 6 and 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ezetimibe/Atorvastatin | 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 |
| Ezetimibe/Atorvastatin | 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 |
| Atorvastatin | Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12 | Week 12 | 58.5 percentage of participants |
| Atorvastatin | Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12 | Week 6 | 38.8 percentage of participants |