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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_010 |
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This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets) | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets) | ||
| VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets) | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets) | ||
| VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets) | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets) | ||
| VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets) | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation | Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment. | Up to 14 days after the treatment discontinuation |
| Mean Percent Change From Baseline to Treatment in Lipid Parameters | The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years. | Baseline and up to 5 years |
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Inclusion Criteria:
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Participants with Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with Vytorin
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| ID | Title | Description |
|---|---|---|
| FG000 | VYTORIN® 10/10 mg/Day to 10/80 mg/Day | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Participants for Safety Evaluation |
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| Participants for Efficacy Evaluation |
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| ID | Title | Description |
|---|---|---|
| BG000 | VYTORIN® 10/10 mg/Day to 10/80 mg/Day | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6. |
| 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, Customized | Number |
| 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 | Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation | Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment. | Posted | Number | Percentage of Participants | Up to 14 days after the treatment discontinuation |
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Year 1 through Year 6. There were no SAE's reported in Year three.
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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 YEAR 1 | Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC ARREST | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000090542 | Homozygous Familial Hypercholesterolemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
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| Violation inclusion criteria/off label |
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| TMT given before date of contract |
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| Participants |
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| Sex/Gender, Customized | Number | participants |
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|
|
| Primary | Mean Percent Change From Baseline to Treatment in Lipid Parameters | The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years. | Posted | Mean | Standard Deviation | percentage change | Baseline and up to 5 years |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | VYTORIN YEAR 2 | Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2 | 4 | 933 | 0 | 933 |
| EG002 | VYTORIN YEAR 4 | Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4 | 6 | 531 | 0 | 531 |
| EG003 | VYTORIN YEAR 5 | Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5 | 0 | 380 | 0 | 380 |
| EG004 | VYTORIN YEAR 6 | Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6 | 5 | 158 | 0 | 158 |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
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| DIABETIC RETINOPATHY | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| RETROPERITONEAL HAEMATOMA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| DIABETIC FOOT | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| GOUTY ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| CERVIX CARCINOMA RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| LDL (n = 1096, 1128, 1012) |
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| TG (n = 1843, 1824, 1766) |
|