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The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe 10 mg | Active Comparator | A whole ezetimibe 10 mg tablet |
|
| Ezetimibe 5 mg | Experimental | Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe 10 mg | Drug | Ezetimibe 10 mg daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL Cholesterol | LDL cholesterol | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | Total cholesterol fasting | 4 weeks |
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Inclusion Criteria:
Subjects receiving ezetimibe 10 mg
Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):
Patients willing and able to provide signed informed consent
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19463517 | Result | Baruch L, Agarwal S, Gupta B, Haynos A, Eng C. Effect on serum lipid levels of switching dose of ezetimibe from 10 to 5 mg. Am J Cardiol. 2009 Jun 1;103(11):1568-71. doi: 10.1016/j.amjcard.2009.01.365. Epub 2009 Apr 22. |
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The drug was prescribed once daily. No patients were excluded after randomization
Patients were recruited from themedical, cardiology and lipid clinics from Spetember 2007 through April 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe 10 mg | A whole ezetimibe 10 mg tablet |
| FG001 | Ezetimibe 5 mg | Ezetimibe 5 mg, |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe 10 mg | A whole ezetimibe 10 mg tablet |
| BG001 | Ezetimibe 5 mg | Ezetimibe 5 mg, |
| 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 | LDL cholesterol | Posted | Mean | Standard Deviation | mg/dL | 4 weeks |
|
|
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The saftey population includes all participants who received at least one dose of study drug and who were not lost to follow up.
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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 10 mg | A whole ezetimibe 10 mg tablet |
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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 |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ezetimibe 5 mg | Drug | Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half |
|
|
| 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 | Total cholesterol fasting | Posted | Mean | Standard Deviation | mg/dL | 4 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Ezetimibe 5 mg | Ezetimibe 5 mg, | 0 | 23 | 0 | 23 |
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| D009750 |
| Nutritional and Metabolic Diseases |