| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates. | Full analysis set; Missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab 280 mg | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG002 | Evolocumab 350 mg | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG003 | Evolocumab 420 mg | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
| | Units | Counts |
|---|
| Participants | - OG00032
- OG00132
- OG00231
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-14.76± 3.94
- OG001-40.77± 3.96
- OG002-42.58± 4.01
- OG003
|
|
| | 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 |
|---|
| The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist. | ANCOVA | The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors. | <0.001 | Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05. | LS Mean Treatment Difference | -35.94 | Standard Error of the Mean | 4.11 | 2-Sided | 95 | -44.08 | -27.80 | | | Ezetimibe is the reference. | |
|
| Primary | Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe | LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates. | Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF and calculated LDL-C. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab + Ezetimibe | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. |
| |
| Secondary | Change From Baseline in LDL-C at Week 12 | LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates. | Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab 280 mg | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG002 | Evolocumab 350 mg | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG003 | Evolocumab 420 mg | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
|
| Secondary | Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe | LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates. | Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab + Ezetimibe | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 | LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates. | Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab 280 mg | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG002 | Evolocumab 350 mg | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG003 | Evolocumab 420 mg | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
|
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe | LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates. | Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab + Ezetimibe | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12 | LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates. | Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab 280 mg | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG002 | Evolocumab 350 mg | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG003 | Evolocumab 420 mg | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
|
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe | LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates. | Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab + Ezetimibe | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates. | Full analysis set; missing data at Week 12 were imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab 280 mg | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG002 | Evolocumab 350 mg | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG003 | Evolocumab 420 mg | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
|
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe | LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates. | Full analysis set; missing data at Week 12 were imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab + Ezetimibe | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates. | Full analysis set; missing data at Week 12 were imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab 280 mg | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG002 | Evolocumab 350 mg | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | | OG003 | Evolocumab 420 mg | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
|
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe | LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates. | Full analysis set; missing data at Week 12 were imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab + Ezetimibe | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. |
| |