| Primary | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. | FAS; n (number) equals (=) number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mMol/L | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET]) | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| | | Title | Denominators | Categories |
|---|
| Baseline (n=139,132) | | | Title | Measurements |
|---|
| - OG0006.304± 1.3130
- OG0015.921± 1.1646
|
| | Month 1 (n=131,130) | | |
| |
| Primary | Percent Change From Baseline in LDL-C | Assessments were performed in the fasting state (minimum 10-hour fast). | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET) | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mMol/L | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in HDL-C | Assessments were performed in the fasting state (minimum 10-hour fast). | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Total Cholesterol (mMol/L) During the Study | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mMol/L | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in Total Cholesterol | Assessments were performed in the fasting state (minimum 10-hour fast). | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Trigylcerides (mMol/L) During the Study | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mMol/L | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in Trigylcerides | Assessments were performed in the fasting state (minimum 10-hour fast). | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | mMol/L | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in VLDL | Assessments were performed in the fasting state (minimum 10-hour fast). | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in Apo A-1 | Assessments were performed in the fasting state (minimum 10-hour fast). | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Apoliprotein B (Apo B; g/L) During the Study | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in Apo B | Assessments were performed in the fasting state (minimum 10-hour fast). | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit. | FAS; n=number of participants assessed for the specific parameter at a given visit. | Posted | | Number | | participants | | Baseline, Months 6, 12, 18, 24, 30, and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg): Baseline Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Baseline Tanner_Stage 2 | Participants aged ≥10 to 15 years, at Tanner_Stage 2 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG002 |
|
| Primary | Height (Centimeters [cm]) During the Study: Males | Investigator assessment of height changes during the study. Change from baseline was also determined. | FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | cm | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in Height: Males | Investigator assessment of height changes during the study. | FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Height (cm) During the Study: Females | Investigator assessment of height changes during the study. Change from baseline was also determined. | FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | cm | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in Height: Females | Investigator assessment of height changes during the study. | FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Weight (Kilograms [kg]) During the Study: Males | Investigator assessment of weight changes during the study. Change from baseline was also determined. | FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | kg | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in Weight: Males | Investigator assessment of weight changes during the study. | FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Weight (kg) During the Study: Females | Investigator assessment of weight changes during the study. Change from baseline was also determined. | FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | kg | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Percent Change From Baseline in Weight: Females | Investigator assessment of weight changes during the study. | FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
| |
| Primary | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Investigator assessment of BMI changes during the study. Change from baseline was also determined. | FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
|---|
| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | Percent Change From Baseline in BMI: Males | Investigator assessment of BMI changes during the study. | FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | BMI (kg/m^2) During the Study: Females | Investigator assessment of BMI changes during the study. Change from baseline was also determined. | FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | Percent Change From Baseline in BMI: Females | Investigator assessment of BMI changes during the study. | FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | Age (Years) During the Study: Males | Investigator assessment of age during the study. Change from baseline was also determined. | FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | years | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | Percent Change From Baseline in Age: Males | Investigator assessment of age during the study. | FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | Age (Years) During the Study: Females | Investigator assessment of age during the study. Change from baseline was also determined. | FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | years | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | Percent Change From Baseline in Age: Females | Investigator assessment of age during the study. | FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg) | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Secondary | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | | FAS; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination) | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | Flow-Mediated Dilatation (FMD) During the Study | Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined. | FMD Set: all participants enrolled in the FMD study who had at least baseline FMD measurements. n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | % FMD | | Baseline, Months 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Primary | Percent Change From Baseline in FMD | Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. | FMD Set; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Mean | Standard Deviation | percent change | | Months 6, 12, 18, 24, 30 and 36/ET | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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| Secondary | Percentage of Participants by Study Drug Compliance Category | Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%. | Safety Analysis Set: all participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | | percentage of participants | | Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination) | | | | ID | Title | Description |
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| OG000 | Atorvastatin (5-80 mg): Tanner_Stage 1 | Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. | | OG001 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. |
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