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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_009 |
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This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of EZETROL® through collecting the safety information according to the Re-examination Regulation for New Drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZETROL® 10 mg | Participants with Hypercholesterolemia treated with EZETROL® |
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| Measure | Description | Time Frame |
|---|---|---|
| Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation | Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment. | Up to 14 days after 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 [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters. | Baseline to 4 weeks |
| Overall Efficacy Evaluation of EZETROL® | Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened. | Baseline to 4 weeks |
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Inclusion Criteria:
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Participants with Hypercholesterolemia treated with EZETROL®
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | EZETROL® 10 mg | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily. |
| 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 | EZETROL® 10 mg | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily. |
| 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 | Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation | Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment. | Posted | Number | participants | Up to 14 days after treatment discontinuation |
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Year 1 through Year 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 | EZETROL Year 1 | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Treatment prior to date of contract |
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| Uncontracted participants |
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| Violation of inclusions & off label use |
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| Duplicated participants & off-label use |
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| participants |
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| Sex: Female, Male | Count of Participants | 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 [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters. | 3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded | Posted | Mean | Standard Deviation | percentage of change | Baseline to 4 weeks |
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|
|
| Primary | Overall Efficacy Evaluation of EZETROL® | Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened. | 3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded | Posted | Number | participants | Baseline to 4 weeks |
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|
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | EZETROL Year 2 | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2. | 3 | 1,135 | 5 | 1,135 |
| EG002 | EZETROL Year 3 | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3. | 18 | 1,039 | 3 | 1,039 |
| EG003 | EZETROL Year 4 | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4. | 9 | 766 | 0 | 766 |
| EG004 | EZETROL Year 5 | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5. | 4 | 154 | 0 | 154 |
| EG005 | EZETROL Year 6 | Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6. | 2 | 375 | 29 | 375 |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| ANGINA UNSTABLE | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| CARDIAC DISORDER | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| DEAFNESS NEUROSENSORY | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| PNEUMONIA | 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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| EXTRADURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| NEUROPATHIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| PARATHYROID TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| DEMENTIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| NEUROLEPTIC MALIGNANT SYNDROME | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| QUADRIPLEGIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| VOCAL CORD POLYP | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| ANGIOPATHY | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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| D009750 |
| Nutritional and Metabolic Diseases |
| Title | Measurements |
|---|---|
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| TG ( n = 2083) |
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| Title | Measurements |
|---|---|
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| Total |
|