| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis. | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-20.39± 3.19
- OG001-59.75± 2.30
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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 |
|---|
| | Repeated measures linear effects model | Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit. | <0.0001 | Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05. | LS Mean Treatment Difference | -39.35 | Standard Error of the Mean | 3.93 | 2-Sided | 95 | -47.23 | -31.48 | | | | | Superiority | |
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| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Change From Baseline in LDL-C at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | Mean low density lipoprotein-cholesterol response was defined as LDL-C < 70 mg/dL [1.8 mol/L]. | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein(a) at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Triglycerides at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in HDL-C at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in VLDL-C at Week 12 | | All randomized participants who received at least 1 dose of study drug in the double-blind treatment period. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe | Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks. | | OG001 | Evolocumab | Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks. |
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