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| ID | Type | Description | Link |
|---|---|---|---|
| MK0653A-121 | |||
| 2007_013 |
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To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C > 2mmol/l, who are able to attain the recommended LDL-C target of < 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Arm 1: Drug |
|
| 2 | Active Comparator | Arm 2: Active comparator |
|
| 3 | Active Comparator | Arm 3: Active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe (+) simvastatin | Drug | ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End | Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end. | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20487050 | Derived | McCormack T, Harvey P, Gaunt R, Allgar V, Chipperfield R, Robinson P; IN-PRACTICE study. Incremental cholesterol reduction with ezetimibe/simvastatin, atorvastatin and rosuvastatin in UK General Practice (IN-PRACTICE): randomised controlled trial of achievement of Joint British Societies (JBS-2) cholesterol targets. Int J Clin Pract. 2010 Jul;64(8):1052-61. doi: 10.1111/j.1742-1241.2010.02429.x. Epub 2010 May 12. |
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All patients were subjected to a 6 week run-in period on open label 40 mg simvastatin to stabilise their LDL-C levels. Patients whose LDL-C at the end of this period was below 2.0 mmol/l or who were <75% compliant with run-in medication, were excluded from the study
Patients with diabetes, cardiovascular disease (CVD) or a "high risk" of developing CVD and a fasting LDL-C level of ≥2mmol/l, having been on simvastatin 40mg for 6 weeks were assigned to 10/40 mg ezetimibe/simvastatin; 40 mg atorvastatin; 10 mg rosuvastatin (5 mg in elderly/Asian patients (in line with UK SPC)) between 27/03/2007 and 31/03/2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe/Simvastatin | ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally |
| FG001 | Atorvostatin | atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Comparator: atorvastatin | Drug | atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally |
|
|
| Comparator: rosuvastatin | Drug | rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally. |
|
|
| FG002 | Rosuvastatin | rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe/Simvastatin | ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally |
| BG001 | Atorvostatin | atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally |
| BG002 | Rosuvastatin | rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End | Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end. | The Full Analysis Set (FAS) all patients who were:
Patients were analysed according to the treatment group they were randomised, regardless of the treatment they received | Posted | Number | Percent | 6 Weeks |
|
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|
|
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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/Simvastatin | ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally | 4 | 6 | ||||
| EG001 | Atorvostatin | atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally | 2 | 1 | ||||
| EG002 | Rosuvastatin | rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally | 4 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Investigations | Medora V10.0 | Systematic Assessment |
| |
| Aortic regurgitation | Cardiac disorders | Medora V10.0 | Systematic Assessment |
| |
| Chest pain | General disorders | Medora V10.0 | Systematic Assessment |
| |
| Oesophageal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medora V10.0 | Systematic Assessment |
| |
| Erthematous rash | Skin and subcutaneous tissue disorders | Medora V10.0 | Systematic Assessment |
| |
| Areterial haemorrhage | Vascular disorders | Medora V10.0 | Systematic Assessment |
| |
| Rectal bleeding | Gastrointestinal disorders | Medora V10.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | Medora V10.0 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medora V10.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Medora V10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Medora V10.0 | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| 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 |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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| >=70 years |
|
| Male |
|
| White |
|
| Black |
|
| Other |
|
| Superiority or Other (legacy) |
| Ho is no difference in proportion achieving the target of LDL-C < 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used. | Regression, Logistic | The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed. | <0.001 | Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025. | 95 | Superiority or Other (legacy) |