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The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with hypercholesterolemia | Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug | 1 tablet of 10 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Measured by Number of Subjects With at Least One Adverse Event | Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event | 28 days after Visit 1 |
| Safety as Measured by Number and Type of Adverse Events. | Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events. | 28 days after Visit 1 |
| Safety as Measured by Severity of Adverse Events as Determined by the Investigator | To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator | 28 days after Visit 1 |
| Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. | To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator. | 28 days after Visit 1 |
| Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event | To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event | 28 days after Visit 1 |
| Safety as Measured by Outcome of Adverse Events | To evaluate overall safety of ezetimibe as measured by outcome of adverse events | 28 days after Visit 1 |
| Tolerability as Measured by Subject Self-assessment |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) | Change in mean total cholesterol values | 28 days after Visit 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Filipino subjects with hypercholesterolemia
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe as Prescribed by the Physician in Normal Practice | Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment |
| 28 days after Visit 1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe as Prescribed by the Physician in Normal Practice | Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not reported for 10 subjects | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex/Gender, Customized | Gender was not reported for 13 subjects | Number | participants |
|
| 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 | Safety as Measured by Number of Subjects With at Least One Adverse Event | Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event | Posted | Number | subjects | 28 days after Visit 1 |
|
|
| |||||||||||||||||||||||||||
| Secondary | To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) | Change in mean total cholesterol values | All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements | Posted | Mean | Standard Deviation | mg/dL | 28 days after Visit 1 |
|
| ||||||||||||||||||||||||||
| Primary | Safety as Measured by Number and Type of Adverse Events. | Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events. | Posted | Number | adverse events | 28 days after Visit 1 |
|
| ||||||||||||||||||||||||||||
| Primary | Safety as Measured by Severity of Adverse Events as Determined by the Investigator | To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator | Posted | Number | adverse events | 28 days after Visit 1 |
|
| ||||||||||||||||||||||||||||
| Primary | Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. | To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator. | Posted | Number | adverse events | 28 days after Visit 1 |
|
| ||||||||||||||||||||||||||||
| Primary | Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event | To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event | Posted | Number | adverse event | 28 days after Visit 1 |
|
| ||||||||||||||||||||||||||||
| Primary | Safety as Measured by Outcome of Adverse Events | To evaluate overall safety of ezetimibe as measured by outcome of adverse events | Posted | Number | adverse events | 28 days after Visit 1 |
|
| ||||||||||||||||||||||||||||
| Primary | Tolerability as Measured by Subject Self-assessment | Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment | Posted | Number | subjects | 28 days after Visit 1 |
|
|
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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 as Prescribed by the Physician in Normal Practice | Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin | 3 | 4,105 | 0 | 4,105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 12.0 |
| ||
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 |
| ||
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 12.0 |
|
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Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.
The prescribing physicians and investigators of this trial will not publish the results of any part of the study without previous written authorization from the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President,Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000090542 | Homozygous Familial Hypercholesterolemia |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Title | Denominators | Categories |
|---|
| gastrointestinal upset |
| |||||
| abdominal pain |
| |||||
| body weakness |
| |||||
| constipation |
| |||||
| crampy abdominal pain |
| |||||
| diarrhea |
| |||||
| dizziness |
| |||||
| epigastric discomfort |
| |||||
| flatulence |
| |||||
| headache |
| |||||
| leg cramps/muscle pain |
| |||||
| mild myalgia |
| |||||
| myalgia |
| |||||
| nausea |
| |||||
| oily flatus |
| |||||
| urticaria |
| |||||
| vague abdominal discomfort |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Mild adverse events |
| |||||
| Moderate adverse events |
| |||||
| Severe adverse events |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Related to treatment |
| |||||
| Not related to treatment |
| |||||
| Relatedness not reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Treatment dosage unchanged |
| |||||
| Treatment dosage reduced |
| |||||
| Treatment temporarily discontinued |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Adverse event cleared |
| |||||
| Adverse event still present |
| |||||
| Adverse event outcome not reported |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Excellent |
| |||||
| Very good |
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| Good |
| |||||
| Fair |
| |||||
| Poor |
| |||||
| Not reported |
|