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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eze/Ato: Ezetimibe/Atorvastatin | Experimental | Participants will receive ezetimibe/atorvastatin 10/40 mg QD from Visit 2 (Day 1) to Visit 3 (Week 6). If the LDL-C target is reached (LDL-C < 55 mg/dL) at Visit 3, maintain the dose to Visit 4 (Week 12). If the LDL-C target level is not reached at Visit 3, dose is increased to ezetimibe/atorvastatin 10/80 mg QD from Visit 3 to Visit 4. |
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| Ato: Atorvastatin | Active Comparator | Participants will receive atorvastatin 40 mg QD from Visit 2 (Day 1) to Visit 3 (Week 6). If the LDL-C target is reached (LDL-C < 55 mg/dL) at Visit 3, maintain the dose to Visit 4 (Week 12). If the LDL-C target is not reached at Visit 3, dose is increased to atorvastatin 80 mg QD from Visit 3 to Visit 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atozet 10/40 mg or 10/80 mg | Drug | Atozet 10/40 mg or 10/80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 6 and 12 |
| Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12 |
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Inclusion Criteria:
Patients who are ≥ 30 years old.
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).
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
Patients with LDL-C levels ≥ 70 mg/dL
Patients who are willing to maintain TLC throughout the study.
Patients who are willing to provide written informed consent prior to study enrollment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| WonYoung Lee | Organon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eunpyeong St. Mary's Hospital | Seoul | Eunpyeong-gu | 03312 | South Korea | ||
| Inje University Ilsan-Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41673582 | Derived | Kang SH, Kwon SU, Lee JY, Seo SM, Nam CW, Park GM, Hong YJ, Lee WY, Jang JE, Chae IH. The role of early ezetimibe combination with atorvastatin in patients with atherosclerotic cardiovascular disease. BMC Cardiovasc Disord. 2026 Feb 11;26(1):233. doi: 10.1186/s12872-026-05594-2. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2024 | Aug 19, 2025 |
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| Lipitor 40 mg or 80 mg | Drug | Lipitor 40 mg or 80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily |
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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. |
| Weeks 6 and 12 |
| 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. | Baseline (Day 1) and 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 | 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. | Baseline (Day 1) and Weeks 6 and 12 |
| 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. | 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 |
| 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. | 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 |
| Goyang-si |
| Gyeonggi-do |
| 10380 |
| South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | Gyeongsangbuk-do | 42601 | South Korea |
| Ulsan University Hospital | Ulsan | Gyeongsangnam-do | 44033 | South Korea |
| Chonnam National University Hospital | Gwangju | Jeollanam-do | 61469 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| FG001 | 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. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The Safety analysis set (SAS) included all randomized participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Low-Density Lipoprotein Cholesterol | Mean | Standard Deviation | mg/dL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline (Day 1) and Week 6 |
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| 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. | 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. | Posted | Number | percentage of participants | Weeks 6 and 12 |
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| 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. | 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. | Posted | Number | percentage of participants | Weeks 6 and 12 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline (Day 1) and Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage change | Baseline (Day 1) and Weeks 6 and 12 |
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| 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. | The SAS included all randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | No | 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 |
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| 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. | The SAS included all randomized participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | No | 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 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 67 | 4 | 67 | 12 | 67 |
| EG001 | 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. | 0 | 69 | 3 | 69 | 11 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
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| AST/ALT ratio abnormal | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Lead, Late-Stage Clinical Development | Organon Korea Co. Ltd | 551-430-6000 | pdrl@organon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2024 | Aug 19, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| OG001 | 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. |
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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.
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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.
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