| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
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| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-23.13(-25.95 to -20.31)
- OG001-8.37(-12.32 to -4.41)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Longitudinal data analysis (LDA) | | <0.001 | | Percent change in least-square means | -14.76 | | | 2-Sided | 95 | -19.61 | -9.91 | | | | | Superiority or Other (legacy) | | |
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| Secondary | In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin | | Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Simvastatin Dose | simvastatin 40 mg tablets, taken once daily for six weeks. |
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| Secondary | In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin | | Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Atorvastatin Dose | atorvastatin 20 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin | | Efficacy data were analyzed primarily based upon the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Number | | participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | | Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg | Posted | | Number | | participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Simvastatin Dose | simvastatin 40 mg tablets, taken once daily for six weeks. |
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| Secondary | In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) | | Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg | Posted | | Number | | participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Atorvastatin Dose | atorvastatin 20 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in Total Cholesterol (TC) | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in Triglycerides | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in LDL-C/HDL-C Ratio | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in TC/HDL-C Ratio | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in Non-HDL-C/HDL-C Ratio | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline Apolipoprotein A-I (Apo A-I) | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in Apo B/Apo A-I Ratio | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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| Secondary | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) | | Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | | OG001 | Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | | OG002 | Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. |
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