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This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe monotherapy without prior treatment | Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | ||
| Ezetimibe monotherpay with prior treatment | Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | ||
| Ezetimibe plus statin | Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin. | ||
| Ezetimibe/simvastatin | Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Cardiovascular (CV) Events | Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years. | up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months | LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively. | Baseline and Month 12 |
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Inclusion criteria:
Exclusion criteria:
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The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27919355 | Result | Ferrieres J, Dallongeville J, Rossignol M, Benichou J, Caro JJ, Getsios D, Hernandez L, Abenhaim L, Grimaldi-Bensouda L. Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population-based study. J Clin Lipidol. 2016 Nov-Dec;10(6):1379-1388. doi: 10.1016/j.jacl.2016.08.015. Epub 2016 Sep 7. |
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All participants who met inclusion criteria and contributed to at least one type of follow-up data in the form of an interview or physician questionnaire were included in the study.
Data was provided by French physicians for participants who were being administered Ezetrol® monotherapy, or Ezetrol® coadministered with a statin, or Inegy® (a fixed-dose combination of ezetimibe and simvastatin.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe Monotherapy Without Prior Treatment | Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). |
| FG001 | Ezetimibe Monotherpay With Prior Treatment | Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). |
| FG002 | Ezetimibe Plus Statin | Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin |
| FG003 | Ezetimibe/Simvastatin | Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe Monotherapy Without Prior Treatment | Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). |
| BG001 | Ezetimibe Monotherpay With Prior Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Cardiovascular (CV) Events | Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years. | All participants with available data for endpoint. | Posted | Number | 95% Confidence Interval | Events per 1000 patient-years | up to 48 months |
|
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There was no plan to systematically collect adverse events for this study.
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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 Monotherapy Without Prior Treatment | Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
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| Percentage of Participants With CV Risk Factors | Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group. | At enrollment (baseline) |
| Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded. | up to 48 months |
| Percentage of Participants With at Least 1 Discontinuation of Study Drug | The percentage of participants who stopped study drug at least once during the study period was recorded and summarized. | up to 48 months |
| Mortality Rate | The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years. | up to 48 months |
Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
| BG002 | Ezetimibe Plus Statin | Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin |
| BG003 | Ezetimibe/Simvastatin | Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). |
| OG002 | Ezetimibe Plus Statin | Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin |
| OG003 | Ezetimibe/Simvastatin | Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). |
|
|
| Secondary | Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months | LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively. | All participants with available data for endpoint. The ezetimibe plus statin and ezetimibe/simvastatin arms were combined for this outcome. | Posted | Mean | Full Range | Percentage Change | Baseline and Month 12 |
|
|
|
| Secondary | Percentage of Participants With CV Risk Factors | Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group. | All enrolled participants with available data | Posted | Number | Percentage of Participants | At enrollment (baseline) |
|
|
|
| Secondary | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded. | All enrolled participants with available data. The ezetimibe monotherapy with or without previous lipid-lowering treatment groups were combined for this outcome. | Posted | Number | Percentage of Participants | up to 48 months |
|
|
|
| Secondary | Percentage of Participants With at Least 1 Discontinuation of Study Drug | The percentage of participants who stopped study drug at least once during the study period was recorded and summarized. | All enrolled participants with available data. | Posted | Number | Percentage of Participants | up to 48 months |
|
|
|
| Secondary | Mortality Rate | The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years. | All enrolled participants with available data. | Posted | Number | 95% Confidence Interval | Deaths per 100,000 patient-years | up to 48 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ezetimibe Monotherapy With Prior Treatment | Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | 0 | 0 | 0 | 0 |
| EG002 | Ezetimibe Plus Statin | Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin | 0 | 0 | 0 | 0 |
| EG003 | Ezetimibe/Simvastatin | Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). | 0 | 0 | 0 | 0 |
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| 1 risk factor |
|
| 2 risk factors |
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| 3 risk factors |
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| 4 risk factors |
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| 5 risk factors |
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| 6 risk factors |
|
|
| 36 months (n=433; 248; 1025) |
|
| 48 months (n=203; 127; 437) |
|