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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_010 |
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The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients with intermediate or high risk dyslipidemia will be enrolled to receive treatment with Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe (+) simvastatin | Drug | Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment. | Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl. | Baseline and week 6 |
| The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment. | Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl. | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 | Baseline and week 6 | |
| Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6 | Baseline and week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 | Baseline and week 6 | |
| Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 | Baseline and week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21699369 | Derived | Huang JC, Lee TY, Liou MJ, Lin CM, Pei D, Chen ZC, Liu RT, Kwok CF. Begin with the real-world patients of non-goal-achieved hypercholesterolemia in taiwan through the ezetimibe/simvastatin tablet - The BRAVO Study. Curr Med Res Opin. 2011 Aug;27(8):1645-51. doi: 10.1185/03007995.2011.594425. Epub 2011 Jun 23. |
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Patients were recruited between August 2007 and July 2009.
In one site, 60 patients among the total 152 study population entered into the 6-week extension period after completing the base period for longer follow-up as per IRB requirement in that site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe/Simvastatin 10/20 mg | Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-week Active Treatment Period |
|
| ||||||||||||||||||||||||
| 6 -Week Extension Period (Single Site) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe/Simvastatin 10/20 mg | Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period |
| 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 | The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment. | Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl. | Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement. | Posted | Number | Percentage of participants | Baseline and week 6 |
|
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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 | Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peptic Ulcer | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| 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 |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6 | Baseline and week 6 |
| Mean Percent Change of Triglycerides From Baseline at Week 6 | Baseline and week 6 |
| Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 | Baseline and week 12 |
| Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12 | Baseline and week 12 |
| Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12 | Baseline and week 12 |
| Mean Percent Change of Triglycerides From Baseline at Week 12 | Baseline and week 12 |
| Out of window period |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Baseline value of Low Density Lipoprotein-C | Mean | Standard Deviation | mg/dL |
|
| Baseline value of Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| Baseline value of High Density Lipoprotein-C | Mean | Standard Deviation | mg/dL |
|
| Baseline value of Triglycerides | Median | Full Range | mg/dL |
|
| Sitting Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Sitting Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period |
|
|
| Primary | The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment. | Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl. | Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement. | Posted | Number | Percentage of participants | Baseline and week 12 |
|
|
|
| Secondary | Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Mean | Standard Deviation | Percent Change | Baseline and week 6 |
|
|
|
| Secondary | Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Mean | Standard Deviation | Percent Change | Baseline and week 6 |
|
|
|
| Secondary | Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Mean | Standard Deviation | Percent Change | Baseline and week 6 |
|
|
|
| Secondary | Mean Percent Change of Triglycerides From Baseline at Week 6 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Median | Inter-Quartile Range | Percent Change | Baseline and week 6 |
|
|
|
| Other Pre-specified | Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 6 |
|
|
|
| Secondary | Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Mean | Standard Deviation | Percent Change | Baseline and week 12 |
|
|
|
| Secondary | Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Mean | Standard Deviation | Percent Change | Baseline and week 12 |
|
|
|
| Secondary | Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Mean | Standard Deviation | Percent Change | Baseline and week 12 |
|
|
|
| Secondary | Mean Percent Change of Triglycerides From Baseline at Week 12 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Median | Inter-Quartile Range | Percent Change | Baseline and week 12 |
|
|
|
| Other Pre-specified | Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 | Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 12 |
|
|
|
| 1 |
| 173 |
| 34 |
| 173 |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Increased Creatine Phosphokinase (CPK) | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Increased Serum Glutamic Pyruvic Transaminase (SGPT) | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
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 |