| Primary | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis | Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-15.6± 3.1
- OG001-47.2± 3.0
|
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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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| Alirocumab group was compared to ezetimibe group using an appropriate contrast statement. | Mixed Models Analysis | | <0.0001 | Threshold for significance ≤ 0.05. | LS Mean Difference | -31.6 | | | 2-Sided | 95 | -40.2 | -23.0 | | | | No | Superiority or Other | | |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | non-HDL-C ITT population. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| |
| Secondary | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis | Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. | | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis | Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| |
| Secondary | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| |
| Secondary | Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| |
| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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| Secondary | Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | | OG001 | Alirocumab 75/Up to 150 mg Q2W | SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
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