| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. | | OG004 | A20 Placebo Q2W | Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks. | | OG005 | A20 Placebo QM | Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks. | | OG006 | A20 Evolocumab Q2W | Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG007 | A20 Evolocumab QM | Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
| | Units | Counts |
|---|
| Participants | - OG00049
- OG00150
- OG00250
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.27± 2.21
- OG0013.91± 2.09
- OG002-73.70± 2.26
- 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 difference in the percent change from baseline at the mean of Weeks 10 and 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 includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group 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 | -73.97 | Standard Error of the Mean | 2.30 | 2-Sided | 95 | -78.54 | -69.41 | | | |
|
| 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
|
| Secondary | Percent Change From Baseline in the 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
|
| Secondary | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
|
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
|
| Secondary | Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
|
| 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
|
| 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 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 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
|
| Secondary | Percent Change From Baseline in VLDL-C at Week 12 | | | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | A5 Placebo Q2W | Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | | OG001 | A5 Placebo QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. | | OG002 | A5 Evolocumab Q2W | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | | OG003 | A5 Evolocumab QM | Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks. |
|