| Secondary | Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. | LDL-C Responders by visit and by risk group - FAS | | Posted | | Mean | 95% Confidence Interval | Percent subjects achieved LDL-C target | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.) |
| | Units | Counts |
|---|
| Participants | - OG000415
- OG00128
- OG00244
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00081.9(77.9 to 85.5)
- OG00185.7(67.3 to 96.0)
- OG00295.5(84.5 to 99.4)
- OG003
|
|
| |
| Secondary | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride | | Posted | | Mean | 95% Confidence Interval | mg/dL (ratio for Scalar) | | Weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.) |
|
| Secondary | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride | Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415). | Posted | | Mean | 95% Confidence Interval | Percent | | weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | |
|
| Secondary | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF) | Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415). | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.) |
|
| Secondary | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF) | Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415). | Posted | | Mean | 95% Confidence Interval | percentage of participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.) |
|
| Secondary | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median baseline, and change from baseline in hs-CRP by risk group - FAS | Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415). | Posted | | Median | 95% Confidence Interval | mg/dL | | 4 and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.) |
|
| Primary | Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. | LDL-C Responders by visit and by risk group - full analysis set (FAS) | N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward) | Posted | | Mean | 95% Confidence Interval | Percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total: sum of all risk groups) | | OG001 | Low Risk | N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | |
|
| Secondary | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Percent change from baseline in hs-CRP by risk group - FAS | Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415). | Posted | | Median | 95% Confidence Interval | percentage | | 4 and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.) |
|
| Secondary | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS | Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408). | Posted | | Median | 95% Confidence Interval | pg/dL | | Baseline, and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.) |
|
| Secondary | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS | Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408). | Posted | | Median | 95% Confidence Interval | percent | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Total | N=425 (Total=sum of all risk groups) | | OG001 | Low Risk | N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.) | | OG002 | Medium Risk | N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.) | | OG003 | High Risk | N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.) |
|