| Primary | Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-30.8(-34.5 to -27.0)
- OG001-10.9(-14.7 to -7.1)
|
|
| | 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 |
|---|
| | ANCOVA | Model terms: treatment and baseline LDL-C value | <0.001 | | Mean Difference (Final Values) | -19.9 | Standard Error of the Mean | 2.7 | | 95 | -25.2 | -14.5 | | | (Atorva + EZ minus Atorva) | | Superiority or Other (legacy) | | |
|
| Secondary | Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change From Baseline in Total-Cholesterol at Week 6 | ([6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change From Baseline in Triglycerides (TG) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Post-Hoc | Percent Change in Apolipoprotein A-I at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | percent | | 6 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Post-Hoc | Percent Change in C-Reactive Protein (CRP) at Week 6 | [(6 week value - baseline value)/baseline value]*100%. | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |
| Secondary | Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6 | | Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | | Number | | Participants | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin + Ezetimibe | Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks | | OG001 | Atorvastatin | Atorvastatin 40 mg Daily for 6 weeks |
| |