| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | 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. | | OG005 | 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 | - OG00076
- OG00178
- OG00277
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.10± 1.67
- OG001-1.34± 1.54
- OG002-17.75± 1.67
- 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 placebo, and the alternative hypothesis was that a mean difference did exist. | Repeated measures linear effects model | The model included treatment group, Baseline LDL-C level, 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 | -57.14 | Standard Error of the Mean | 2.03 | 2-Sided | 95 | -61.14 | -53.14 | | | |
|
| Primary | Percent Change From Baseline in LDL-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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W | |
|
| Secondary | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| Secondary | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| Secondary | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 |
|
| 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W | |
|
| 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| Secondary | Percent Change From Baseline in 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 |
|
| Secondary | Percent Change From Baseline in 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| Secondary | Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 | | | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| Secondary | Percent Change From Baseline in Lipoprotein (a) at Week 12 | | | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W | |
|
| Secondary | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | | | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| Secondary | Percent Change From Baseline in Triglycerides at Week 12 | | | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W | |
|
| Secondary | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | | | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| Secondary | Percent Change From Baseline in VLDL-C at Week 12 | | | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W | |
|
| Secondary | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 | | | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Weeks 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W |
|
| Secondary | Percent Change From Baseline in HDL-C at Week 12 | | | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. | | OG002 | Ezetimibe (Q2W) | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG003 | Ezetimibe (QM) | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. | | OG004 | Evolocumab Q2W | |
|