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The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe + Atorvastatin | Experimental | Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg |
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| Atorvastatin | Active Comparator | Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg |
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| Rosuvastatin | Active Comparator | Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug | 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values | LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation). | End of Week 4 to Week 16 or discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in LDL-C | LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation). | End of washout period to Week 16 or discontinuation |
| Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24653510 | Result | Teramoto T, Sawada T, Iwamoto K, Daida H. Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia-Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):16-40. doi: 10.1016/j.curtheres.2012.02.002. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe + Atorvastatin | Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg |
| FG001 | Atorvastatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Atorvastatin | Drug | 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16) |
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| Atorvastatin | Drug | 2 tablets of 10 mg daily for 12 weeks (Weeks 5-16) |
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| Rosuvastatin | Drug | 1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16) |
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LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation). Target values: For participants with history of coronary artery disease: <100 mg/dL; for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL; for participants with 1-2 CV risk factors: <140 mg/dL; for participants with no CV risk factors: <160 mg/dL. |
| Week 16 or discontinuation |
| Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP) | Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation. | End of Week 4 to Week 16 or discontinuation |
| Percent Change in Total Lipids and Hs-CRP | Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation). | End of washout to Week 16 or discontinuation |
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
| FG002 | Rosuvastatin | Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe + Atorvastatin | Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg |
| BG001 | Atorvastatin | Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg |
| BG002 | Rosuvastatin | Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg |
| BG003 | 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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| Region of Enrollment | Number | participants |
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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 | Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values | LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation). | Randomized participants | Posted | Mean | 95% Confidence Interval | Percent change | End of Week 4 to Week 16 or discontinuation |
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| Secondary | Percent Change in LDL-C | LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation). | Randomized participants | Posted | Mean | 95% Confidence Interval | Percent change | End of washout period to Week 16 or discontinuation |
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| Secondary | Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values | LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation). Target values: For participants with history of coronary artery disease: <100 mg/dL; for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL; for participants with 1-2 CV risk factors: <140 mg/dL; for participants with no CV risk factors: <160 mg/dL. | Randomized participants | Posted | Number | Participants | Week 16 or discontinuation |
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| Secondary | Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP) | Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation. | Randomized participants | Posted | Mean | 95% Confidence Interval | Percent change | End of Week 4 to Week 16 or discontinuation |
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| Secondary | Percent Change in Total Lipids and Hs-CRP | Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation). | Randomized participants | Posted | Mean | 95% Confidence Interval | Percent change | End of washout to Week 16 or discontinuation |
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Randomized participants
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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 + Atorvastatin | Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg | 4 | 47 | 13 | 47 | ||
| EG001 | Atorvastatin | Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg | 1 | 46 | 5 | 46 | ||
| EG002 | Rosuvastatin | Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg | 0 | 32 | 9 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest discomfort | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Heat illness | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Carcinoid tumour of the gastrointestinal tract | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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The investigator agrees not to publish/present any interim results of the study without Sponsor's prior written consent. The investigator further agrees to provide to the sponsor 45 days prior to submission, review copies of abstracts/manuscripts that report any study results. The sponsor has the right to review and comment. If the parties disagree, investigator agrees to meet with the sponsor for the purpose of making good faith efforts to discuss and resolve any such issues or disagreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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| Male |
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| Mean Difference (Net) |
| -26.5 |
| 2-Sided |
| 95 |
| -31.8 |
| -21.2 |
| Superiority or Other (legacy) |
| Participants |
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