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The main objective of this study is to determine the percentage of patients who met the low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin monotherapy treatment.
The type of patient sampling used was consecutive patient sampling
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects treated with INEGY | Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INEGY | Drug | Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reaching the Targeted LDL-C Levels | A subject was considered to have met targeted LDL-C levels (been controlled) if:
| 1 to 3 months after starting treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Treated With INEGY | Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Treated With INEGY | Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg). |
| 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 | Number of Participants Reaching the Targeted LDL-C Levels | A subject was considered to have met targeted LDL-C levels (been controlled) if:
| This was the efficacy population per protocol (PP) targeted for study treatment, and consisted of patients having taken INEGY at least once, with a primary efficacy criterion available (presence of risk factors or not plus lipid assessment after introduction of INEGY), and showing no major deviations from the protocol. | Posted | Number | Participants | 1 to 3 months after starting treatment |
|
4 weeks to 3 months
Adverse events were recorded from the introduction of INEGY to the first assessment after introduction of INEGY
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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 | Subjects Treated With INEGY | Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Endocrine disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Subjects Treated With INEGY |
Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg). |
|
|
| 2 |
| 1,663 |
| 0 |
| 1,663 |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
The results of this non-interventional study can be published or presented by members of the scientific committee after revision and agreement by Schering-Plough, and in such a way that the confidential information and industrial property are not revealed. Before publication or presentation, a copy of the final text must be sent by the member(s) of the scientific committee to Schering-Plough for comment.
| 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 |