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The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1Vytorin 10/80 divided into 4 | Active Comparator | Vytorin 10/80 divided into 4 |
|
| Simvastatin | Active Comparator | Simvastatin 20 milligrams |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vytorin | Drug | Vytorin 10/80 split into 4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| LDL Cholesterol | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Baruch, MD | Bronx VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bronx VA Medical Center | The Bronx | New York | 10468 | United States |
There was no washout phase during the study. No patients were excluded after enrollment.
Thirty-four patients were randomized from August 2007 through October 2008. Patients were recruited from our cardiology and lipid clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1Vytorin 10/80 Divided Into 4 | Vytorin 10/80 divided into 4 |
| FG001 | Simvastatin | Simvastatin 20 milligrams |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1Vytorin 10/80 Divided Into 4 | Vytorin 10/80 divided into 4 |
| BG001 | Simvastatin | Simvastatin 20 milligrams |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | LDL Cholesterol | Posted | Mean | Standard Deviation | % change in LDL cholesterol | 6 weeks |
|
|
6 weeks
One patient never received the simvastatin in the simvastatin arm.
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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 | 1Vytorin 10/80 Divided Into 4 | Vytorin 10/80 divided into 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle pain-Myalgia | Musculoskeletal and connective tissue disorders | SNOMED CT | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lawrence Baruch | Bronx VA Medical Center | 718-584-9000 | 6776 | lawrence.baruch@va.gov |
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| 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 |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Simvastatin |
| Drug |
Simvastatin 20 milligrams |
|
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Total Cholesterol | Posted | Mean | Standard Deviation | % change in total cholesterol | 6 weeks |
|
|
|
| 0 |
| 17 |
| 2 |
| 17 |
| EG001 | Simvastatin | Simvastatin 20 milligrams | 0 | 16 | 0 | 16 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| 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 |