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This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filipino Patients with Hypercholesterolemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vytorin (R) (Ezetimibe + Simvastatin) | Drug | Vytorin (R) (Ezetimibe + Simvastatin) 1 tablet once daily to be taken by mouth in the evening for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had an Adverse Event (AE). | The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE. | Throughout study up to Day 29 (Final Visit) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18 years old and above seen in the outpatient clinic who were diagnosed to have hypercholesterolemia. Patients with primary (heterozygous familial and non - familial) hypercholesterolemia or homozygous familial hypercholesterolemia were also included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Filipino Patients With Hypercholesterolemia |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Filipino Patients With Hypercholesterolemia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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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 | Number of Participants Who Had an Adverse Event (AE). | The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE. | Posted | Number | participants | Throughout study up to Day 29 (Final Visit) |
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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 | Filipino Patients With Hypercholesterolemia | 4 | 4,748 | 0 | 4,748 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Patient died. |
| ||
| Death | General disorders |
| |||
| Multi-organ failure | General disorders | Patient died. |
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Other disclosures agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 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 |
| D000069438 | Ezetimibe |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| 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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