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| ID | Type | Description | Link |
|---|---|---|---|
| MK0653A-129 | |||
| 2007_017 |
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Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vytorin® | Experimental | simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks |
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| atorvastatin | Active Comparator | atorvastatin 10 mg; tablet, once daily, 8 Weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simvastatin (+) ezetimibe | Drug | simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | Baseline and 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk). | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | Baseline and Week 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Patients who have Metabolic syndrome and Hypercholesterolemia had 4 weeks wash-out period were enrolled in this study. The eligible patients was allocated to one of Vytorin 10/20 mg or Atorvastatin 10 mg group.
Patients were recruited between June 2007 and May 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vytorin | simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks |
| FG001 | Atorvastatin | atorvastatin 10 mg; tablet, once daily, 8 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: atorvastatin | Drug | atorvastatin 10 mg; tablet, once daily, 8 Weeks |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vytorin | simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks |
| BG001 | Atorvastatin | atorvastatin 10 mg; tablet, once daily, 8 Weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| LDL-C (low-Density-Lipoprotein-Cholesterol) | Mean | Standard Deviation | mg/dL |
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| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| 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 | Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks. | All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment. | Posted | Mean | Standard Deviation | Percent of Baseline Value | Baseline and 8 Weeks |
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| Secondary | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. | Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk). | All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment. | Posted | Number | Participants attaining LDL-C goal | Baseline and 8 weeks |
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| Other Pre-specified | Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks. | All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 8 |
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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 | simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks | 1 | 25 | ||||
| EG001 | Atorvastatin | atorvastatin 10 mg; tablet, once daily, 8 Weeks | 1 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic enzyme increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic enzyme increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| High Density lipoprotein decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Blood Insulin Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Bood Urea Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Neurological symptom | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Chest discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Tinnitus | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Myodesopsia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral coldness | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D009750 | Nutritional and 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 |
| 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 |
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| Male |
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