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| ID | Type | Description | Link |
|---|---|---|---|
| MK0653A-092 | |||
| 2005_070 |
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This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vytorin | Experimental | Ezetimibe 10 mg/Simvastatin 20 mg |
|
| Atorvastatin | Active Comparator | Atorvastatin 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe (+) simvastatin | Drug | simvastatin/ezetimibe 10/20 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C Lowering Efficacy | LDL-C = low density lipoprotein cholesterol, measured in mg/dl. | 6 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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After a 4-week diet/wash-out period, patients still at or above drug treatment thresholds established by National Cholesterol Education Program Adult Treatment Panel III Guidelines were randomized. Randomization was stratified according to LDL-C levels obtained 1 week pre-randomization: ≥130 to <160 mg/dL; ≥160 to <190 mg/dL; ≥190 mg/dL.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vytorin | Ezetimibe 10 mg/Simvastatin 20 mg |
| FG001 | Atorvastatin | Atorvastatin 10 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vytorin | Ezetimibe 10 mg/Simvastatin 20 mg |
| BG001 | Atorvastatin | Atorvastatin 10 mg |
| 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 | LDL-C Lowering Efficacy | LDL-C = low density lipoprotein cholesterol, measured in mg/dl. | Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point. | Posted | Least Squares Mean | Standard Deviation | Percent Change from Baseline | 6 weeks |
|
|
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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 | Vytorin | Ezetimibe 10 mg/Simvastatin 20 mg |
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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 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| atorvastatin | Drug | atorvastatin 10 mg |
|
|
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata | Number | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Counts |
|---|
| Participants |
|
|
|
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | Atorvastatin | Atorvastatin 10 mg | 0 | 95 | 0 | 95 |
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.
| D009750 |
| Nutritional and Metabolic Diseases |
| 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 |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |