| Primary | Percent Change From Baseline in LDL-C at Week 12 | | Full analysis set (all randomized participants who received at least 1 dose of investigational product (subcutaneously or orally)) with available data (no imputation was performed). | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| | Units | Counts |
|---|
| Participants | - OG00051
- OG00151
- OG002103
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-18.08± 2.52
- OG001-15.05± 2.13
- OG002-56.14± 1.91
- 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 is no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist. | Repeated measures linear effects model | The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit. | <0.001 | Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05. | LS Mean Treatment Difference | -38.06 | Standard Error of the Mean | 2.87 | 2-Sided | 95 | -43.73 | -32.99 | | | | |
|
| Secondary | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Change From Baseline in LDL-C at Week 12 | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L) | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein (a) at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Triglycerides at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |
| Primary | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | | Full analysis set with available data (no imputation was performed). | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG001 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG002 | Evolocumab Q2W | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| |