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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_552 |
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This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Arm 1: drug |
|
| 2 | Active Comparator | Arm 2: active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe (+) simvastatin | Drug | ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment | Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment | The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment. The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Cholesterol | Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks |
| Percent Change From Baseline in Triglycerides. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19222610 | Background | Farnier M, Averna M, Missault L, Vaverkova H, Viigimaa M, Massaad R, Vandormael K, Johnson-Levonas AO, Brudi P. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. Int J Clin Pract. 2009 Apr;63(4):547-59. doi: 10.1111/j.1742-1241.2009.02022.x. Epub 2009 Feb 16. | |
| 21859750 |
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Eligible participants were randomized at Visit 2 (Week 6) to either a combination tablet of ezetimibe/simvastatin (10 mg/20 mg) plus a matching placebo for rosuvastatin 10 mg (Group 1) or rosuvastatin 10 mg plus a matching placebo for the combination tablet (Group 2) for a 6-week treatment period.
Phase IV
First Participant In: 31-Mar-2007; Last Participant Last Visit 11-Mar-2008
85 centers worldwide (EX US)
Eligible participants include those on a stable dose of one of the following: rosuvastatin 5 mg; simvastatin 20 mg, 40 mg; atorvastatin 10, 20 mg; pravastatin 40 mg; fluvastatin 80 mg.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetemibe + Simvastatin | Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks |
| FG001 | Rosuvastatin | Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Comparator : rosuvastatin calcium | Drug | rosuvastatin 10mg. The treatment duration will be 6 weeks. |
|
| Comparator: Placebo (unspecified) | Drug | rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks. |
|
| Comparator: Placebo (unspecified) | Drug | ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks. |
|
| after 6 weeks of treatment |
Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. |
| Baseline and 6 weeks |
| Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) | Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks |
| Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) | Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks |
| Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio | Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks |
| Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio | Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks |
| Percent Change From Baseline in Apolipoprotein B | Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks |
| Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein | Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Baseline and 6 weeks |
| Derived |
| Averna M, Missault L, Vaverkova H, Farnier M, Viigimaa M, Dong Q, Shah A, Johnson-Levonas AO, Taggart W, Brudi P. Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome. Diab Vasc Dis Res. 2011 Oct;8(4):262-70. doi: 10.1177/1479164111418136. Epub 2011 Aug 22. |
| 21050476 | Derived | Viigimaa M, Vaverkova H, Farnier M, Averna M, Missault L, Hanson ME, Dong Q, Shah A, Brudi P. Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency. Lipids Health Dis. 2010 Nov 4;9:127. doi: 10.1186/1476-511X-9-127. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetemibe + Simvastatin | Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks |
| BG001 | Rosuvastatin | Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks |
| 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 | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Apolipoprotein B | Median | Standard Deviation | mg/dL |
| |||||||||||||||
| C Reactive Protein | Median | Standard Deviation | mg/dL |
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| High Density Lipoprotein-Cholesterol | Mean | Standard Deviation | mg/dL |
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| Low Density Lipoprotein-Cholesterol (LDL-C) | Mean | Standard Deviation | mg/dL |
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| Low Density Lipoprotein-Cholesterol (LDL-C):High Density Lipoprotein-Cholesterol (HDL-C) ratio | Mean | Standard Deviation | LDL-C:HDL-C ratio |
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| Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) | Mean | Standard Deviation | mg/dL |
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| Total Cholesterol | Mean | Standard Deviation | mg/dL |
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| Total cholesterol:High Density Lipoprotein-Cholesterol (HDL-C) ratio | Mean | Standard Deviation | Total cholesterol:HDL-C ratio |
| |||||||||||||||
| Triglycerides | Median | 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 | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment | Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment | The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment. The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group. | Full Analysis Set (FAS) | Posted | Number | Percent of participant population | after 6 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Total Cholesterol | Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
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| Other Pre-specified | Percent Change From Baseline in Triglycerides. | Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Median | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
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| Other Pre-specified | Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) | Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
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| Other Pre-specified | Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) | Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
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| Other Pre-specified | Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio | Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
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| Other Pre-specified | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio | Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
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| Other Pre-specified | Percent Change From Baseline in Apolipoprotein B | Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
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| Other Pre-specified | Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein | Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. | Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. | Posted | Median | 95% Confidence Interval | percent change from baseline | Baseline and 6 weeks |
|
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Adverse event tables include all participants who took at least one dose of study drug.
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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 | Ezetemibe + Simvastatin | Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks | 3 | 19 | ||||
| EG001 | Rosuvastatin | Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks | 5 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholangitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Subarachnoid hemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
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| Epileptic seizure | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Skin eruption | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomitting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
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| Pain | General disorders | MedDRA | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Deafness traumatic | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Syncope vasovagal | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000069438 | Ezetimibe |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Not Hispanic or Latino |
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