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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe/Simvastatin 10/20 mg + Simvastatin placebo | Experimental | Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment |
|
| Ezetimibe/Simvastatin placebo + Simvastatin 40 mg | Active Comparator | Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe/Simvastatin 10/20 mg | Drug | 1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks | Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment. | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria: subjects who have the following medical conditions:
Exclusion Criteria: subjects who are on any of the following concomitant medications:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21122660 | Derived | Averna M, Zaninelli A, Le Grazie C, Gensini GF. Ezetimibe/simvastatin 10/20 mg versus simvastatin 40 mg in coronary heart disease patients. J Clin Lipidol. 2010 Jul-Aug;4(4):272-8. doi: 10.1016/j.jacl.2010.05.002. Epub 2010 Jun 1. | |
| 20663203 | Derived | Rotella CM, Zaninelli A, Le Grazie C, Hanson ME, Gensini GF. Ezetimibe/simvastatin vs simvastatin in coronary heart disease patients with or without diabetes. Lipids Health Dis. 2010 Jul 27;9:80. doi: 10.1186/1476-511X-9-80. |
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Visits 1 and 2 were for screening, combined if wash-out not required. One ineligible subject mistakenly received assignment at Visit 2 and was removed. The subject did not receive treatment. Actual enrollment: 120 subjects. Intent-to-treat (ITT) population included only evaluable subjects; as such analysis based on 112 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo | Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| simvastatin 40 mg | Drug | 1 tablet containing 40 mg of simvastatin per day for 6 weeks |
|
| Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg |
Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo | Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment |
| BG001 | Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg | Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age based on Intent-to-Treat population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Gender totals based on Intent-to-Treat population. | Count of Participants | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks | Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment. | Intent-to-treat population only. | Posted | Mean | Standard Deviation | percentage change | Baseline and 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 | Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo | Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment | 0 | 60 | 0 | 60 | ||
| EG001 | Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg | Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment. | 1 | 60 | 0 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischemic Attack | Cardiac disorders | Systematic Assessment |
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The investigator shall not publish or publicly present the study results without prior written authorization from the sponsor, except for dispositions in the Ministerial Circular n. 6 dated 02 SEP 2002. The investigator shall notify the sponsor in writing of any publication submission or presentation reporting results of the study 30 days prior to submission or presentation to permit sponsor review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
|