| 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| | Units | Counts |
|---|
| Participants | - OG000164
- OG001160
- OG002325
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0004.94± 3.48
- OG0010.99± 3.31
- OG002-65.35± 3.09
- 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 |
|---|
| | Repeated measures linear effects model | The model includes treatment group, entry statin therapy and geographic region, 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 | -70.29 | Standard Error of the Mean | 2.61 | 2-Sided | 95 | -75.43 | -65.16 | | | Treatment difference = Evolocumab Q2W - Placebo Q2W | | Superiority | |
|
| Primary | Percent Change From Baseline in 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B100 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B100 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Total 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-C 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-C 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B100/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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B100/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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally 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 | Placebo Q2W | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |
| Secondary | Percent Change From Baseline in VLDL-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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG001 | Placebo QM | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin 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 20 mg atorvastatin orally once a day for up to 12 weeks. | | OG003 | Evolocumab QM | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| |