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Trial record 49 of 153 for:    "familial hypercholesterolemia"

Atorvastatin Three Year Pediatric Study

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ClinicalTrials.gov Identifier: NCT00827606
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : June 2, 2015
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Familial Hypercholesterolemia
Intervention Drug: atorvastatin
Enrollment 272

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description Participants aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (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 low-density lipoprotein cholesterol (LDL-C) (<3.35 millimoles per liter [mmol/L]) was not attained. Participants aged greater than or equal to (≥) 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.
Period Title: Overall Study
Started 139 132
Completed 112 94
Not Completed 27 38
Reason Not Completed
Protocol Violation             4             3
Lost to Follow-up             3             1
Withdrawal by Subject             7             6
Pregnancy             0             1
Not specified             5             13
LDL below 2.59 mmol/L             4             12
Adverse Event             4             2
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+ Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 139 132 271
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): all participants who took at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants 132 participants 271 participants
8.5  (1.86) 12.0  (1.68) 10.2  (2.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 132 participants 271 participants
Female
46
  33.1%
79
  59.8%
125
  46.1%
Male
93
  66.9%
53
  40.2%
146
  53.9%
1.Primary Outcome
Title Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n (number) equals (=) number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 139 132
Mean (Standard Deviation)
Unit of Measure: mMol/L
Baseline (n=139,132) 6.304  (1.3130) 5.921  (1.1646)
Month 1 (n=131,130) 4.087  (1.0264) 3.675  (0.8749)
Change at Month 1 (n=131,130) -2.214  (0.7568) -2.233  (0.8009)
Month 2 (n=132,122) 3.719  (0.8346) 3.437  (0.7438)
Change at Month 2 (n=132,122) -2.586  (0.9297) -2.554  (0.9155)
Month 3 (n=126,117) 3.503  (0.7566) 3.270  (0.6533)
Change at Month 3 (n=126,117) -2.798  (1.0251) -2.795  (1.0835)
Month 6 (n=127,115) 3.366  (0.5787) 3.347  (0.5953)
Change at Month 6 (n=127,115) -2.968  (1.1096) -2.732  (1.0660)
Month 12 (n=121,109) 3.409  (0.7395) 3.196  (0.6565)
Change at Month 12 (n=121,109) -2.966  (1.0987) -2.838  (1.1450)
Month 18 (n=116,101) 3.309  (0.5933) 3.261  (0.5288)
Change at Month 18 (n=116,101) -3.105  (1.1558) -2.835  (1.2128)
Month 24 (n=111,96) 3.316  (0.6803) 3.189  (0.6537)
Change at Month 24 (n=111,96) -3.088  (1.2026) -2.933  (1.2292)
Month 30 (n=112,94) 3.335  (0.6490) 3.142  (0.6916)
Change at Month 30 (n=112,94) -3.090  (1.2402) -3.008  (1.1489)
Month 36/ET (n=123,117) 3.450  (0.7372) 3.457  (0.8808)
Change at Month 36/ET (n=123,117) -2.855  (1.2625) -2.468  (1.3270)
2.Primary Outcome
Title Percent Change From Baseline in LDL-C
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 132 130
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=131,130) -34.995  (9.7300) -37.516  (10.0245)
Month 2 (n=132,122) -40.371  (9.6468) -41.939  (10.4816)
Month 3 (n=126,117) -43.568  (10.2149) -44.887  (12.7530)
Month 6 (n=127,115) -45.647  (9.6969) -43.697  (11.1836)
Month 12 (n=121,109) -45.530  (10.5112) -45.727  (13.5336)
Month 18 (n=116,101) -47.101  (10.5592) -44.818  (13.2623)
Month 24 (n=111,96) -46.944  (11.9490) -46.417  (13.8658)
Month 30 (n=112,94) -46.631  (12.0206) -47.734  (12.6696)
Month 36/ET (n=123,117) -43.785  (13.5585) -39.863  (17.5411)
3.Primary Outcome
Title High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 139 132
Mean (Standard Deviation)
Unit of Measure: mMol/L
Baseline (n=139,132) 1.349  (0.2732) 1.277  (0.2546)
Month 1 (n=131,130) 1.360  (0.2717) 1.292  (0.2650)
Change at Month 1 (n=131,130) 0.010  (0.1685) 0.016  (0.1740)
Month 2 (n=132,122) 1.364  (0.2805) 1.297  (0.2625)
Change at Month 2 (n=132,122) 0.014  (0.2238) 0.025  (0.1600)
Month 3 (n=126,117) 1.371  (0.2768) 1.274  (0.2606)
Change at Month 3 (n=126,117) 0.015  (0.1943) 0.011  (0.1837)
Month 6 (n=127,115) 1.337  (0.2834) 1.268  (0.2311)
Change at Month 6 (n=127,115) -0.011  (0.1848) 0.010  (0.1833)
Month 12 (n=121,109) 1.328  (0.2885) 1.241  (0.2429)
Change at Month 12 (n=121,109) -0.012  (0.1945) -0.023  (0.1727)
Month 18 (n=116,102) 1.367  (0.3003) 1.234  (0.2349)
Change at Month 18 (n=116,102) 0.024  (0.1923) -0.027  (0.1744)
Month 24 (n=111,96) 1.385  (0.2729) 1.266  (0.2443)
Change at Month 24 (n=111,96) 0.027  (0.2043) 0.007  (0.1910)
Month 30 (n=112,94) 1.380  (0.2942) 1.265  (0.2487)
Change at Month 30 (n=112,94) 0.032  (0.1997) 0.006  (0.2150)
Month 36/ET (n=123,117) 1.335  (0.2918) 1.278  (0.2516)
Change at Month 36/ET (n=123,117) -0.024  (0.1949) 0.005  (0.1975)
4.Primary Outcome
Title Percent Change From Baseline in HDL-C
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 132 130
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=131,130) 1.526  (12.7845) 2.192  (14.0769)
Month 2 (n=132,122) 2.195  (15.6882) 2.544  (12.7802)
Month 3 (n=126,117) 1.929  (14.7329) 1.674  (14.9525)
Month 6 (n=127,115) -0.016  (14.8853) 1.877  (14.9113)
Month 12 (n=121,109) -0.069  (15.2821) -1.023  (14.1983)
Month 18 (n=116,102) 2.472  (14.8939) -1.165  (14.3783)
Month 24 (n=111,96) 3.014  (14.9559) 1.737  (15.6924)
Month 30 (n=112,94) 3.345  (15.5080) 1.868  (17.2633)
Month 36/ET (n=123,117) -1.125  (14.7816) 1.602  (15.4895)
5.Primary Outcome
Title Total Cholesterol (mMol/L) During the Study
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 139 132
Mean (Standard Deviation)
Unit of Measure: mMol/L
Baseline (n=139,132) 8.056  (1.3356) 7.647  (1.2250)
Month 1 (n=134,131) 5.785  (1.0497) 5.352  (0.9345)
Change at Month 1 (n=134,131) -2.266  (0.7957) -2.297  (0.8516)
Month 2 (n=132,124) 5.435  (0.8629) 5.061  (0.7865)
Change at Month 2 (n=132,124) -2.620  (0.9581) -2.654  (0.9707)
Month 3 (n=127,118) 5.195  (0.8000) 4.883  (0.7034)
Change at Month 3 (n=127,118) -2.869  (1.0904) -2.883  (1.1363)
Month 6 (n=127,115) 5.019  (0.6380) 4.982  (0.6620)
Change at Month 6 (n=127,115) -3.063  (1.1687) -2.809  (1.1133)
Month 12 (n=121,109) 5.081  (0.7470) 4.799  (0.7176)
Change at Month 12 (n=121,109) -3.040  (1.1353) -2.945  (1.2112)
Month 18 (n=116,101) 4.989  (0.6512) 4.845  (0.5401)
Change at Month 18 (n=116,101) -3.168  (1.1990) -2.965  (1.2667)
Month 24 (n=111,96) 5.032  (0.7111) 4.817  (0.7413)
Change at Month 24 (n=111,96) -3.123  (1.2039) -3.009  (1.2871)
Month 30 (n=112,95) 5.075  (0.6951) 4.795  (0.8256)
Change at Month 30 (n=112,95) -3.096  (1.2999) -3.048  (1.2716)
Month 36/ET (n=123,117) 5.134  (0.7863) 5.099  (0.9318)
Change at Month 36/ET (n=123,117) -2.923  (1.3256) -2.543  (1.3669)
6.Primary Outcome
Title Percent Change From Baseline in Total Cholesterol
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 134 131
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=134,131) -27.879  (8.2639) -29.653  (8.5987)
Month 2 (n=132,124) -31.900  (8.5025) -33.726  (9.2319)
Month 3 (n=127,118) -34.784  (9.4141) -36.126  (11.0136)
Month 6 (n=127,115) -36.889  (9.2297) -35.055  (10.0273)
Month 12 (n=121,109) -36.541  (9.2486) -36.943  (11.9418)
Month 18 (n=116,101) -37.772  (9.7325) -36.634  (11.4572)
Month 24 (n=111,96) -37.287  (9.9578) -37.317  (12.2461)
Month 30 (n=112,95) -36.662  (11.2064) -37.856  (12.5116)
Month 36/ET (n=123,117) -35.063  (12.0345) -32.013  (14.5000)
7.Primary Outcome
Title Trigylcerides (mMol/L) During the Study
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 139 132
Mean (Standard Deviation)
Unit of Measure: mMol/L
Baseline (n=139,132) 0.880  (0.4343) 0.980  (0.4986)
Month 1 (n=134,131) 0.759  (0.3958) 0.815  (0.3848)
Change at Month 1 (n=134,131) -0.121  (0.3895) -0.166  (0.5024)
Month 2 (n=132,124) 0.772  (0.3837) 0.741  (0.3382)
Change at Month 2 (n=132,124) -0.103  (0.3652) -0.246  (0.4825)
Month 3 (n=127,118) 0.699  (0.2916) 0.748  (0.3357)
Change at Month 3 (n=127,118) -0.166  (0.3937) -0.237  (0.4466)
Month 6 (n=127,115) 0.691  (0.3602) 0.801  (0.3848)
Change at Month 6 (n=127,115) -0.183  (0.4305) -0.188  (0.4880)
Month 12 (n=121,109) -0.747  (0.3901) 0.789  (0.4050)
Change at Month 12 (n=121,109) -0.136  (0.4060) -0.181  (0.5255)
Month 18 (n=116,102) 0.687  (0.3435) 0.765  (0.3438)
Change at Month 18 (n=116,102) -0.190  (0.3665) -0.219  (0.4623)
Month 24 (n=111,96) 0.725  (0.3676) 0.790  (0.3651)
Change at Month 24 (n=111,96) -0.133  (0.4112) -0.179  (0.4956)
Month 30 (n=112,95) 0.788  (0.3454) 0.781  (0.4167)
Change at Month 30 (n=112,95) -0.082  (0.3898) -0.187  (0.5728)
Month 36/ET (n=123,117) 0.764  (0.4220) 0.794  (0.3894)
Change at Month 36/ET (n=123,117) -0.092  (0.4615) -0.171  (0.5216)
8.Primary Outcome
Title Percent Change From Baseline in Trigylcerides
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 134 131
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=134,131) -5.950  (39.0995) -5.927  (51.1811)
Month 2 (n=132,124) -3.260  (42.5136) -14.832  (40.4952)
Month 3 (n=127,118) -8.760  (41.1184) -14.415  (39.9951)
Month 6 (n=127,115) -11.817  (41.9879) -9.097  (43.0350)
Month 12 (n=121,109) -7.981  (40.4511) -7.950  (48.7238)
Month 18 (n=116,102) -13.113  (39.3990) -12.443  (37.3822)
Month 24 (n=111,96) -6.697  (38.7027) -7.328  (45.3694)
Month 30 (n=112,95) 0.657  (43.3886) -4.935  (63.1887)
Month 36/ET (n=123,117) -0.703  (50.6333) -7.759  (45.6372)
9.Primary Outcome
Title Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 139 132
Mean (Standard Deviation)
Unit of Measure: mMol/L
Baseline (n=139,132) 0.403  (0.1993) 0.449  (0.2288)
Month 1 (n=134,131) 0.348  (0.1823) 0.374  (0.1770)
Change at Month 1 (n=134,131) -0.056  (0.1793) -0.076  (0.2307)
Month 2 (n=132,124) 0.354  (0.1757) 0.340  (0.1541)
Change at Month 2 (n=132,124) -0.047  (0.1672) -0.113  (0.2215)
Month 3 (n=127,118) 0.320  (0.1333) 0.344  (0.1548)
Change at Month 3 (n=127,118) -0.076  (0.1805) -0.108  (0.2044)
Month 6 (n=127,115) 0.317  (0.1652) 0.367  (0.1767)
Change at Month 6 (n=127,115) -0.084  (0.1977) -0.086  (0.2240)
Month 12 (n=121,109) 0.343  (0.1786) 0.362  (0.1862)
Change at Month 12 (n=121,109) -0.062  (0.1872) -0.082  (0.2421)
Month 18 (n=116,101) 0.315  (0.1571) 0.349  (0.1571)
Change at Month 18 (n=116,101) -0.087  (0.1680) -0.102  (0.2126)
Month 24 (n=111,96) 0.332  (0.1680) 0.363  (0.1680)
Change at Month 24 (n=111,96) -0.061  (0.1887) -0.081  (0.2285)
Month 30 (n=112,95) 0.361  (0.1581) 0.358  (0.1914)
Change at Month 30 (n=112,95) -0.038  (0.1781) -0.086  (0.2621)
Month 36/ET (n=123,117) 0.350  (0.1930) 0.364  (0.1782)
Change at Month 36/ET (n=123,117) -0.042  (0.2112) -0.079  (0.2385)
10.Primary Outcome
Title Percent Change From Baseline in VLDL
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 134 131
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=134,131) -6.060  (39.3300) -5.805  (51.7264)
Month 2 (n=132,124) -3.097  (42.3626) -14.694  (40.1710)
Month 3 (n=127,118) -8.711  (41.2631) -14.263  (39.7239)
Month 6 (n=127,115) -11.591  (42.4219) -9.158  (43.1397)
Month 12 (n=121,109) -7.739  (40.7579) -7.827  (48.9819)
Month 18 (n=116,101) -12.911  (39.7908) -12.768  (37.4142)
Month 24 (n=111,96) -6.654  (38.7945) -6.920  (46.3317)
Month 30 (n=112,95) 0.627  (43.6239) -4.751  (64.2502)
Month 36/ET (n=123,117) -0.520  (51.3422) -7.842  (45.4640)
11.Primary Outcome
Title Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 138 132
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (n=138,132) 1.396  (0.1839) 1.308  (0.2006)
Month 1 (n=132,130) 1.419  (0.2233) 1.337  (0.1927)
Change at Month 1 (n=132,130) 0.025  (0.1639) 0.032  (0.1506)
Month 2 (n=131,123) 1.411  (0.1952) 1.334  (0.1950)
Change at Month 2 (n=131,123) 0.016  (0.1519) 0.025  (0.1355)
Month 3 (n=126,117) 1.405  (0.1914) 1.306  (0.1919)
Change at Month 3 (n=126,117) 0.005  (0.1713) 0.006  (0.1557)
Month 6 (n=123,110) 1.386  (0.2081) 1.329  (0.1894)
Change at Month 6 (n=123,110) -0.007  (0.1609) 0.026  (0.1818)
Month 12 (n=120,108) 1.347  (0.1893) 1.271  (0.1798)
Change at Month 12 (n=120,108) -0.041  (0.1574) -0.028  (0.1586)
Month 18 (n=114,100) 1.339  (0.1972) 1.266  (0.1676)
Change at Month 18 (n=114,100) -0.049  (0.1558) -0.038  (0.1643)
Month 24 (n=113,95) 1.364  (0.1929) 1.275  (0.1736)
Change at Month 24 (n=113,95) -0.032  (0.1749) -0.027  (0.1799)
Month 30 (n=112,95) 1.357  (0.2247) 1.268  (0.1848)
Change at Month 30 (n=112,95) -0.040  (0.1857) -0.036  (0.1861)
Month 36/ET (n=125,118) 1.327  (0.2081) 1.272  (0.1664)
Change at Month 36/ET (n=125,118) -0.073  (0.1725) -0.040  (0.1676)
12.Primary Outcome
Title Percent Change From Baseline in Apo A-1
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 132 130
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=132,130) 2.229  (12.4001) 3.301  (12.2009)
Month 2 (n=131,123) 1.701  (11.0364) 2.499  (10.7656)
Month 3 (n=126,117) 1.041  (12.4204) 1.192  (12.1640)
Month 6 (n=123,110) -0.069  (12.1109) 3.011  (14.1347)
Month 12 (n=120,108) -2.365  (11.5882) -1.370  (12.3901)
Month 18 (n=114,100) -3.042  (11.2219) -1.980  (12.2170)
Month 24 (n=113,95) -1.611  (12.4618) -0.961  (13.9868)
Month 30 (n=112,95) -2.342  (13.3357) -1.695  (14.2732)
Month 36/ET (n=125,118) -4.804  (12.0443) -1.954  (12.7229)
13.Primary Outcome
Title Apoliprotein B (Apo B; g/L) During the Study
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 138 132
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (n=138,132) 1.454  (0.2890) 1.381  (0.2619)
Month 1 (n=132,130) 1.062  (0.2423) 0.967  (0.2257)
Change at Month 1 (n=132,130) -0.395  (0.1599) -0.415  (0.1691)
Month 2 (n=131,123) 0.980  (0.1929) 0.916  (0.1813)
Change at Month 2 (n=131,123) -0.471  (0.1825) -0.484  (0.1858)
Month 3 (n=126,117) 0.930  (0.1836) 0.890  (0.1707)
Change at Month 3 (n=126,117) -0.522  (0.2152) -0.518  (0.2184)
Month 6 (n=123,110) 0.919  (0.1557) 0.910  (0.1683)
Change at Month 6 (n=123,110) -0.535  (0.2092) -0.503  (0.2086)
Month 12 (n=120,108) 0.918  (0.1816) 0.871  (0.1493)
Change at Month 12 (n=120,108) -0.548  (0.2131) -0.530  (0.2194)
Month 18 (n=114,100) 0.893  (0.1546) 0.882  (0.1293)
Change at Month 18 (n=114,100) -0.578  (0.2343) -0.533  (0.2463)
Month 24 (n=113,95) 0.918  (0.1719) 0.884  (0.1575)
Change at Month 24 (n=113,95) -0.551  (0.2353) -0.535  (0.2344)
Month 30 (n=112,95) 0.910  (0.1723) 0.885  (0.1717)
Change at Month 30 (n=112,95) -0.560  (0.2664) -0.533  (0.2467)
Month 36/ET (n=125,118) 0.926  (0.1860) 0.924  (0.2173)
Change at Month 36/ET (n=125,118) -0.520  (0.2730) -0.450  (0.2748)
14.Primary Outcome
Title Percent Change From Baseline in Apo B
Hide Description Assessments were performed in the fasting state (minimum 10-hour fast).
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 132 130
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=132,130) -26.933  (9.5550) -29.851  (10.3544)
Month 2 (n=131,123) -31.867  (9.2821) -33.959  (9.9478)
Month 3 (n=126,117) -35.163  (10.5680) -35.849  (11.6832)
Month 6 (n=123,110) -35.900  (9.3398) -34.740  (10.7982)
Month 12 (n=120,108) -36.624  (9.7413) -36.842  (11.6106)
Month 18 (n=114,100) -38.158  (10.4084) -36.211  (12.7805)
Month 24 (n=113,95) -36.426  (11.4333) -36.677  (12.1824)
Month 30 (n=112,95) -36.668  (12.8783) -36.453  (13.6888)
Month 36/ET (n=125,118) -34.507  (14.0740) -31.362  (16.4770)
15.Primary Outcome
Title Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage
Hide Description 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.
Time Frame Baseline, Months 6, 12, 18, 24, 30, and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specific parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Baseline Tanner_Stage 1 Atorvastatin (10-80 mg): Baseline Tanner_Stage 2 Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 Atorvastatin (10-80 mg): Baseline Tanner_Stage 5
Hide Arm/Group Description:
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.
Participants aged ≥10 to 15 years, at Tanner_Stage 3 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, PO, 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.
Participants aged ≥10 to 15 years, at Tanner_Stage 4 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, PO, 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.
Participants aged ≥10 to 15 years, at Tanner_Stage 5 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, PO, 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.
Overall Number of Participants Analyzed 127 52 25 31 18
Measure Type: Number
Unit of Measure: participants
Tanner_Stage 1, Month 6 (n=126,48,25,27,15) 107 0 0 0 0
Tanner_Stage 2 , Month 6 (n=126,48,25,27,15) 14 34 0 0 0
Tanner_Stage 3, Month 6 (n=126,48,25,27,15) 5 10 14 0 0
Tanner_Stage 4, Month 6 (n=126,48,25,27,15) 0 4 11 25 1
Tanner_Stage 5, Month 6 (n=126,48,25,27,15) 0 0 0 2 14
Tanner_Stage 1, Month 12 (n=121,43,23,26,15) 85 0 0 0 0
Tanner_Stage 2, Month 12 (n=121,43,23,26,15) 25 17 0 0 0
Tanner_Stage 3, Month 12 (n=121,43,23,26,15) 10 21 11 0 0
Tanner_Stage 4, Month 12 (n=121,43,23,26,15) 1 5 10 22 1
Tanner_Stage 5, Month 12 (n=121,43,23,26,15) 0 0 2 4 14
Tanner_Stage 1, Month 18 (n=115,41, 21,25,14) 63 0 0 0 0
Tanner_Stage 2, Month 18 (n=115,41, 21,25,14) 31 15 0 0 0
Tanner_Stage 3, Month 18 (n=115,41, 21,25,14) 18 16 6 0 0
Tanner_Stage 4, Month 18 (n=115,41, 21,25,14) 3 9 11 18 1
Tanner_Stage 5, Month 18 (n=115,41, 21,25,14) 0 1 4 7 13
Tanner_Stage 1, Month 24 (n=113,38,19,22,14) 51 0 0 0 0
Tanner_Stage 2, Month 24 (n=113,38,19,22,14) 33 9 0 0 0
Tanner_Stage 3, Month 24 (n=113,38,19,22,14) 20 14 2 0 0
Tanner_Stage 4, Month 24 (n=113,38,19,22,14) 9 12 13 13 1
Tanner_Stage 5, Month 24 (n=113,38,19,22,14) 0 3 4 9 13
Tanner_Stage 1, Month 30 (n=111,38,19,23,14) 39 0 0 0 0
Tanner_Stage 2, Month 30 (n=111,38,19,23,14) 32 3 0 0 0
Tanner_Stage 3, Month 30 (n=111,38,19,23,14) 26 11 1 0 0
Tanner_Stage 4, Month 30 (n=111,38,19,23,14) 14 18 9 11 1
Tanner_Stage 5, Month 30 (n=111,38,19,23,14) 0 6 9 12 13
Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18) 41 0 0 0 0
Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18) 31 6 0 0 0
Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18) 25 10 2 0 0
Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18) 25 24 13 12 0
Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18) 5 12 10 19 18
16.Primary Outcome
Title Height (Centimeters [cm]) During the Study: Males
Hide Description Investigator assessment of height changes during the study. Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 146
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (n=146) 144.36  (16.004)
Month 1 (n=141) 145.21  (16.114)
Change at Month 1 (n=141) 0.68  (0.964)
Month 2 (n=138) 145.93  (16.302)
Change at Month 2 (n=138) 1.27  (0.964)
Month 3 (n=133) 146.00  (16.139)
Change at Month 3 (n=133) 1.72  (1.172)
Month 6 (n=129) 147.17  (16.033)
Change at Month 6 (n=129) 3.24  (1.485)
Month 12 (n=123) 150.75  (16.321)
Change at Month 12 (n=123) 6.67  (2.385)
Month 18 (n=119) 153.26  (16.388)
Change at Month 18 (n=119) 9.31  (2.978)
Month 24 (n=114) 156.03  (16.001)
Change at Month 24 (n=114) 12.11  (3.630)
Month 30 (n=114) 158.78  (15.770)
Change at Month 30 (n=114) 14.86  (4.403)
Month 36/ET (n=134) 160.59  (15.602)
Change at Month 36/ET (n=134) 15.53  (6.801)
17.Primary Outcome
Title Percent Change From Baseline in Height: Males
Hide Description Investigator assessment of height changes during the study.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 141
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=141) 0.47  (0.689)
Month 2 (n=138) 0.88  (0.652)
Month 3 (n=133) 1.19  (0.777)
Month 6 (n=129) 2.25  (0.987)
Month 12 (n=123) 4.66  (1.606)
Month 18 (n=119) 6.53  (2.021)
Month 24 (n=114) 8.53  (2.607)
Month 30 (n=114) 10.49  (3.260)
Month 36/ET (n=134) 10.97  (5.010)
18.Primary Outcome
Title Height (cm) During the Study: Females
Hide Description Investigator assessment of height changes during the study. Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (n=125) 145.28  (14.108)
Month 1 (n=124) 146.06  (14.045)
Change at Month 1 (n=124) 0.71  (1.378)
Month 2 (n=119) 146.57  (13.919)
Change at Month 2 (n=119) 1.19  (1.700)
Month 3 (n=115) 146.81  (13.838)
Change at Month 3 (n=115) 1.68  (1.278)
Month 6 (n=113) 147.87  (13.619)
Change at Month 6 (n=113) 2.77  (1.720)
Month 12 (n=107) 150.84  (12.968)
Change at Month 12 (n=107) 5.50  (2.992)
Month 18 (n=99) 152.77  (12.648)
Change at Month 18 (n=99) 7.41  (4.043)
Month 24 (n=95) 154.79  (11.913)
Change at Month 24 (n=95) 9.61  (5.120)
Month 30 (n=93) 156.43  (11.288)
Change at Month 30 (n=93) 11.23  (6.118)
Month 36/ET (n=121) 156.52  (11.032)
Change at Month 36/ET (n=121) 11.23  (7.551)
19.Primary Outcome
Title Percent Change From Baseline in Height: Females
Hide Description Investigator assessment of height changes during the study.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=124) 0.51  (1.004)
Month 2 (n=119) 0.84  (1.220)
Month 3 (n=115) 1.20  (0.925)
Month 6 (n=113) 1.98  (1.291)
Month 12 (n=107) 3.93  (2.262)
Month 18 (n=99) 5.30  (3.036)
Month 24 (n=95) 6.93  (3.933)
Month 30 (n=93) 8.13  (4.740)
Month 36/ET (n=121) 8.14  (5.789)
20.Primary Outcome
Title Weight (Kilograms [kg]) During the Study: Males
Hide Description Investigator assessment of weight changes during the study. Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 146
Mean (Standard Deviation)
Unit of Measure: kg
Baseline (n=146) 40.79  (14.079)
Month 1 (n=141) 41.18  (14.287)
Change at Month 1 (n=141) 0.36  (1.203)
Month 2 (n=138) 41.83  (14.467)
Change at Month 2 (n=138) 0.80  (1.422)
Month 3 (n=133) 41.68  (14.266)
Change at Month 3 (n=133) 1.08  (1.907)
Month 6 (n=129) 42.47  (14.564)
Change at Month 6 (n=129) 2.00  (2.528)
Month 12 (n=123) 45.29  (15.526)
Change at Month 12 (n=123) 4.65  (3.822)
Month 18 (n=119) 47.53  (16.164)
Change at Month 18 (n=119) 7.02  (4.432)
Month 24 (n=114) 49.77  (16.401)
Change at Month 24 (n=114) 9.27  (5.079)
Month 30 (n=114) 52.12  (17.100)
Change at Month 30 (n=114) 11.61  (6.032)
Month 36/ET (n=134) 53.50  (16.787)
Change at Month 36/ET (n=134) 12.35  (6.771)
21.Primary Outcome
Title Percent Change From Baseline in Weight: Males
Hide Description Investigator assessment of weight changes during the study.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 141
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=141) 0.94  (2.739)
Month 2 (n=138) 2.04  (3.262)
Month 3 (n=133) 2.73  (4.317)
Month 6 (n=129) 5.09  (5.559)
Month 12 (n=123) 11.85  (8.172)
Month 18 (n=119) 18.03  (9.629)
Month 24 (n=114) 24.28  (11.696)
Month 30 (n=114) 30.46  (14.058)
Month 36/ET (n=134) 32.54  (17.409)
22.Primary Outcome
Title Weight (kg) During the Study: Females
Hide Description Investigator assessment of weight changes during the study. Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: kg
Baseline (n=125) 42.14  (14.038)
Month 1 (n=125) 42.50  (14.007)
Change at Month 1 (n=125) 0.36  (0.924)
Month 2 (n=120) 42.86  (14.209)
Change at Month 2 (n=120) 0.67  (1.338)
Month 3 (n=115) 43.34  (14.753)
Change at Month 3 (n=115) 1.24  (1.819)
Month 6 (n=113) 44.26  (15.027)
Change at Month 6 (n=113) 2.10  (2.409)
Month 12 (n=107) 46.61  (15.158)
Change at Month 12 (n=107) 4.41  (3.317)
Month 18 (n=99) 48.32  (14.670)
Change at Month 18 (n=99) 6.24  (4.291)
Month 24 (n=95) 50.13  (14.731)
Change at Month 24 (n=95) 8.55  (5.038)
Month 30 (n=93) 51.73  (14.681)
Change at Month 30 (n=93) 10.02  (6.127)
Month 36/ET (n=121) 51.55  (14.498)
Change at Month 36/ET (n=121) 9.77  (7.047)
23.Primary Outcome
Title Percent Change From Baseline in Weight: Females
Hide Description Investigator assessment of weight changes during the study.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=125) 0.97  (2.303)
Month 2 (n=120) 1.85  (3.206)
Month 3 (n=115) 3.16  (4.149)
Month 6 (n=113) 5.37  (5.529)
Month 12 (n=107) 11.65  (8.391)
Month 18 (n=99) 16.79  (11.315)
Month 24 (n=95) 23.43  (14.333)
Month 30 (n=93) 27.83  (17.507)
Month 36/ET (n=121) 27.26  (21.389)
24.Primary Outcome
Title Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males
Hide Description Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 146
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Baseline (n=146) 18.97  (3.664)
Month 1 (n=141) 18.94  (3.751)
Change at Month 1 (n=141) 0.01  (0.577)
Month 2 (n=138) 19.06  (3.755)
Change at Month 2 (n=138) 0.06  (0.658)
Month 3 (n=133) 18.99  (3.745)
Change at Month 3 (n=133) 0.07  (0.890)
Month 6 (n=129) 19.04  (3.881)
Change at Month 6 (n=129) 0.10  (1.218)
Month 12 (n=123) 19.34  (3.922)
Change at Month 12 (n=123) 0.37  (1.541)
Month 18 (n=119) 19.65  (4.053)
Change at Month 18 (n=119) 0.73  (1.625)
Month 24 (n=114) 19.91  (4.098)
Change at Month 24 (n=114) 0.99  (1.745)
Month 30 (n=114) 20.18  (4.400)
Change at Month 30 (n=114) 1.25  (2.099)
Month 36/ET (n=134) 20.28  (4.137)
Change at Month 36/ET (n=134) 1.33  (1.958)
25.Primary Outcome
Title Percent Change From Baseline in BMI: Males
Hide Description Investigator assessment of BMI changes during the study.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 141
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=141) 0.03  (2.953)
Month 2 (n=138) 0.31  (3.405)
Month 3 (n=133) 0.39  (4.496)
Month 6 (n=129) 0.55  (5.673)
Month 12 (n=123) 2.10  (7.065)
Month 18 (n=119) 3.98  (7.533)
Month 24 (n=114) 5.45  (8.306)
Month 30 (n=114) 6.80  (9.737)
Month 36/ET (n=134) 7.31  (9.290)
26.Primary Outcome
Title BMI (kg/m^2) During the Study: Females
Hide Description Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Baseline (n=125) 19.44  (3.994)
Month 1 (n=124) 19.45  (3.973)
Change at Month 1 (n=124) -0.02  (0.582)
Month 2 (n=119) 19.47  (3.940)
Change at Month 2 (n=119) 0.00  (0.756)
Month 3 (n=115) 19.54  (4.171)
Change at Month 3 (n=115) 0.13  (0.861)
Month 6 (n=113) 19.68  (4.288)
Change at Month 6 (n=113) 0.24  (1.004)
Month 12 (n=107) 19.98  (4.257)
Change at Month 12 (n=107) 0.60  (1.305)
Month 18 (n=99) 20.24  (3.990)
Change at Month 18 (n=99) 0.92  (1.432)
Month 24 (n=95) 20.50  (3.976)
Change at Month 24 (n=95) 1.38  (1.624)
Month 30 (n=93) 20.75  (4.014)
Change at Month 30 (n=93) 1.59  (1.931)
Month 36/ET (n=121) 20.71  (4.217)
Change at Month 36/ET (n=121) 1.46  (1.948)
27.Primary Outcome
Title Percent Change From Baseline in BMI: Females
Hide Description Investigator assessment of BMI changes during the study.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=124) -0.06  (3.058)
Month 2 (n=119) 0.16  (3.777)
Month 3 (n=115) 0.73  (4.314)
Month 6 (n=113) 1.26  (4.992)
Month 12 (n=107) 3.33  (6.765)
Month 18 (n=99) 5.14  (7.578)
Month 24 (n=95) 7.68  (8.661)
Month 30 (n=93) 8.89  (9.916)
Month 36/ET (n=121) 8.06  (10.147)
28.Primary Outcome
Title Age (Years) During the Study: Males
Hide Description Investigator assessment of age during the study. Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 146
Mean (Standard Deviation)
Unit of Measure: years
Baseline (n=146) 9.94  (2.489)
Month 1 (n=141) 10.05  (2.553)
Change at Month 1 (n=141) 0.11  (0.309)
Month 2 (n=138) 10.14  (2.583)
Change at Month 2 (n=138) 0.18  (0.387)
Month 3 (n=133) 10.21  (2.567)
Change at Month 3 (n=133) 0.29  (0.457)
Month 6 (n=129) 10.43  (2.552)
Change at Month 6 (n=129) 0.55  (0.499)
Month 12 (n=123) 10.96  (2.543)
Change at Month 12 (n=123) 1.02  (0.155)
Month 18 (n=119) 11.47  (2.544)
Change at Month 18 (n=119) 1.54  (0.501)
Month 24 (n=114) 11.93  (2.534)
Change at Month 24 (n=114) 2.02  (0.132)
Month 30 (n=114) 12.46  (2.553)
Change at Month 30 (n=114) 2.54  (0.500)
Month 36/ET (n=134) 12.69  (2.587)
Change at Month 36/ET (n=134) 2.67  (0.899)
29.Primary Outcome
Title Percent Change From Baseline in Age: Males
Hide Description Investigator assessment of age during the study.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 141
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=141) 1.09  (3.327)
Month 2 (n=138) 1.86  (4.184)
Month 3 (n=133) 3.16  (5.175)
Month 6 (n=129) 6.06  (5.956)
Month 12 (n=123) 11.13  (3.878)
Month 18 (n=119) 16.82  (7.732)
Month 24 (n=114) 21.92  (6.623)
Month 30 (n=114) 27.67  (9.855)
Month 36/ET (n=134) 28.90  (13.486)
30.Primary Outcome
Title Age (Years) During the Study: Females
Hide Description Investigator assessment of age during the study. Change from baseline was also determined.
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: years
Baseline (n=125) 10.55  (2.421)
Month 1 (n=125) 10.66  (2.436)
Change at Month 1 (n=125) 0.11  (0.317)
Month 2 (n=120) 10.78  (2.430)
Change at Month 2 (n=120) 0.20  (0.402)
Month 3 (n=115) 10.75  (2.449)
Change at Month 3 (n=115) 0.28  (0.450)
Month 6 (n=113) 10.99  (2.477)
Change at Month 6 (n=113) 0.52  (0.502)
Month 12 (n=107) 11.50  (2.416)
Change at Month 12 (n=107) 0.99  (0.097)
Month 18 (n=99) 12.02  (2.503)
Change at Month 18 (n=99) 1.52  (0.502)
Month 24 (n=95) 12.42  (2.482)
Change at Month 24 (n=95) 1.98  (0.144)
Month 30 (n=93) 12.99  (2.564)
Change at Month 30 (n=93) 2.52  (0.502)
Month 36/ET (n=121) 13.07  (2.547)
Change at Month 36/ET (n=121) 2.54  (0.940)
31.Primary Outcome
Title Percent Change From Baseline in Age: Females
Hide Description Investigator assessment of age during the study.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 (n=125) 1.10  (3.169)
Month 2 (n=120) 2.00  (4.128)
Month 3 (n=115) 2.74  (4.549)
Month 6 (n=113) 5.18  (5.221)
Month 12 (n=107) 10.00  (2.811)
Month 18 (n=99) 15.20  (6.006)
Month 24 (n=95) 20.08  (5.298)
Month 30 (n=93) 25.35  (7.415)
Month 36/ET (n=121) 25.73  (12.168)
32.Primary Outcome
Title Flow-Mediated Dilatation (FMD) During the Study
Hide Description Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.
Time Frame Baseline, Months 6, 12, 18, 24, 30 and 36/ET
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Hide Analysis Population Description
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.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 37 36
Mean (Standard Deviation)
Unit of Measure: % FMD
Baseline (n=37,36) 5.523  (3.2062) 6.651  (4.4926)
Month 6 (n=27,23) 5.749  (2.5047) 6.520  (4.0763)
Change at Month 6 (n=27,23) -0.063  (3.4768) -0.759  (4.8732)
Month 12 (n=32,29) 4.732  (1.8477) 6.363  (8.0370)
Change at Month 12 (n=32,29) -0.952  (3.6796) -0.778  (9.4743)
Month 18 (n=33,28) 4.942  (2.6740) 4.668  (3.8874)
Change at Month 18 (n=33,28) -0.762  (3.7374) -2.556  (6.3123)
Month 24 (n=33,28) 4.538  (2.4239) 5.679  (4.3224)
Change at Month 24 (n=33,28) -1.166  (3.2524) -1.545  (7.2325)
Month 30 (n=33,28) 5.571  (2.7198) 5.191  (2.5120)
Change at Month 30 (n=33,28) -0.134  (3.3399) -2.033  (5.8591)
Month 36/ET (n=34,33) 4.987  (2.2540) 5.360  (2.9873)
Change at Month 36/ET (n=34,33) -0.550  (3.6625) -1.563  (4.8355)
33.Primary Outcome
Title Percent Change From Baseline in FMD
Hide Description Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
Time Frame Months 6, 12, 18, 24, 30 and 36/ET
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Hide Analysis Population Description
FMD Set; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 34 33
Mean (Standard Deviation)
Unit of Measure: percent change
Month 6 (n=27,23) 14.867  (67.6028) -0.205  (60.7192)
Month 12 (n=32,29) -3.880  (56.1910) 15.444  (207.6932)
Month 18 (n=33,28) -4.598  (68.0267) -24.387  (81.5683)
Month 24 (n=33,28) -9.992  (57.3868) 3.850  (102.2001)
Month 30 (n=33,28) 7.000  (63.0894) -18.804  (42.2259)
Month 36/ET (n=34,33) 0.648  (62.5814) -7.506  (61.2361)
34.Secondary Outcome
Title Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
Hide Description [Not Specified]
Time Frame Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)
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Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 139 132
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n=139,132) 99.3 100.0
Month 1 (n=118,113) 100.0 100.0
Month 2 (n=116,109) 100.0 100.0
Month 3 (n=130,118) 100.0 100.0
Month 6 (n=127,115) 100.0 99.1
Month 12 (n=121,109) 100.0 99.1
Month 18 (n=115,102) 100.0 100.0
Month 24 (n=113,95) 100.0 100.0
Month 30 (n=111,94) 100.0 98.9
Month 36/Early Termination (n=128,127) 99.2 99.2
35.Secondary Outcome
Title Percentage of Participants by Study Drug Compliance Category
Hide Description Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.
Time Frame Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 135 132
Measure Type: Number
Unit of Measure: percentage of participants
Month 1, <80% (n=135,132) 3.0 6.8
Month 1, 80%-120% (n=135,132) 97.0 93.2
Month 1, >120% (n=135,132) 0 0
Month 2, <80% (n=132,126) 6.8 7.9
Month 2, 80%-120% (n=132,126) 92.4 92.1
Month 2, >120% (n=132,126) 0.8 0
Month 3, <80% (n=130,118) 3.8 7.6
Month 3, 80%-120% (n=130,118) 95.4 92.4
Month 3, >120% (n=130,118) 0.8 0
Month 6, <80% (n=127,115) 7.9 9.6
Month 6, 80%-120% (n=127,115) 92.1 90.4
Month 6, >120% (n=127,115) 0 0
Month 12, <80% (n=121,109) 7.4 7.3
Month 12, 80%-120% (n=121,109) 92.6 92.7
Month 12, >120% (n=121,109) 0 0
Month 18, <80% (n=116,102) 4.3 5.9
Month 18, 80%-120% (n=116,102) 94.0 94.1
Month 18, >120% (n=116,102) 1.7 0
Month 24, <80% (n=113,95) 8.8 9.5
Month 24, 80%-120% (n=113,95) 91.2 89.5
Month 24, >120% (n=113,95) 0 1.1
Month 30, <80% (n=112,94) 8.0 6.4
Month 30, 80%-120% (n=112,94) 92.0 92.6
Month 30, >120% (n=112,94) 0 1.1
Month 36/ET, <80% (n=129,129) 11.6 16.3
Month 36/ET, 80%-120% (n=129,129) 86.8 83.7
Month 36/ET, >120% (n=129,129) 1.6 0
Time Frame Baseline up through Month 36
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Affected / at Risk (%) Affected / at Risk (%)
Total   14/139 (10.07%)   7/132 (5.30%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/139 (0.72%)  1/132 (0.76%) 
Appendix disorder * 1  1/139 (0.72%)  0/132 (0.00%) 
Haemorrhoids * 1  1/139 (0.72%)  0/132 (0.00%) 
Vomiting * 1  0/139 (0.00%)  1/132 (0.76%) 
General disorders     
Feeling abnormal * 1  1/139 (0.72%)  0/132 (0.00%) 
Infections and infestations     
Appendicitis * 1  2/139 (1.44%)  0/132 (0.00%) 
Viral infection * 1  1/139 (0.72%)  0/132 (0.00%) 
Injury, poisoning and procedural complications     
Concussion * 1  1/139 (0.72%)  0/132 (0.00%) 
Limb injury * 1  0/139 (0.00%)  1/132 (0.76%) 
Lumbar vertebral fracture * 1  0/139 (0.00%)  1/132 (0.76%) 
Thoracic vertebral fracture * 1  0/139 (0.00%)  1/132 (0.76%) 
Ulna fracture * 1  1/139 (0.72%)  0/132 (0.00%) 
Metabolism and nutrition disorders     
Obesity * 1  0/139 (0.00%)  1/132 (0.76%) 
Type I diabetes mellitus * 1  0/139 (0.00%)  1/132 (0.76%) 
Musculoskeletal and connective tissue disorders     
Myositis * 1  1/139 (0.72%)  0/132 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ewing's sarcoma * 1  1/139 (0.72%)  0/132 (0.00%) 
Intravascular papillary endothelial hyperplasia * 1  1/139 (0.72%)  0/132 (0.00%) 
Nervous system disorders     
Syncope * 1  1/139 (0.72%)  1/132 (0.76%) 
Psychiatric disorders     
Bipolar disorder * 1  1/139 (0.72%)  0/132 (0.00%) 
Suicide attempt * 1  0/139 (0.00%)  1/132 (0.76%) 
Reproductive system and breast disorders     
Testsicular appendage torsion * 1  1/139 (0.72%)  0/132 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atorvastatin (5-80 mg): Tanner_Stage 1 Atorvastatin (10-80 mg): Tanner_Stage 2+
Affected / at Risk (%) Affected / at Risk (%)
Total   93/139 (66.91%)   86/132 (65.15%) 
Gastrointestinal disorders     
Abdominal pain * 1  21/139 (15.11%)  10/132 (7.58%) 
Abdominal pain upper * 1  7/139 (5.04%)  3/132 (2.27%) 
Diarrhoea * 1  8/139 (5.76%)  9/132 (6.82%) 
Nausea * 1  3/139 (2.16%)  8/132 (6.06%) 
Vomiting * 1  15/139 (10.79%)  7/132 (5.30%) 
General disorders     
Pyrexia * 1  15/139 (10.79%)  13/132 (9.85%) 
Infections and infestations     
Nasopharyngitis * 1  26/139 (18.71%)  26/132 (19.70%) 
Bronchitis * 1  9/139 (6.47%)  1/132 (0.76%) 
Ear infection * 1  9/139 (6.47%)  6/132 (4.55%) 
Gastroenteritis * 1  17/139 (12.23%)  12/132 (9.09%) 
Influenza * 1  13/139 (9.35%)  14/132 (10.61%) 
Pharyngitis * 1  9/139 (6.47%)  8/132 (6.06%) 
Respiratory tract infection * 1  7/139 (5.04%)  0/132 (0.00%) 
Rhinitis * 1  13/139 (9.35%)  9/132 (6.82%) 
Tonsillitis * 1  10/139 (7.19%)  6/132 (4.55%) 
Upper respiratory tract infection * 1  20/139 (14.39%)  10/132 (7.58%) 
Viral upper respiratory tract infection * 1  13/139 (9.35%)  3/132 (2.27%) 
Investigations     
Blood creatine phosphokinase increased * 1  3/139 (2.16%)  9/132 (6.82%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  10/139 (7.19%)  5/132 (3.79%) 
Myalgia * 1  4/139 (2.88%)  10/132 (7.58%) 
Pain in extremity * 1  14/139 (10.07%)  5/132 (3.79%) 
Nervous system disorders     
Headache * 1  25/139 (17.99%)  25/132 (18.94%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  14/139 (10.07%)  11/132 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00827606     History of Changes
Other Study ID Numbers: A2581173
2008-006130-95 ( EudraCT Number )
First Submitted: January 21, 2009
First Posted: January 23, 2009
Results First Submitted: September 11, 2014
Results First Posted: June 2, 2015
Last Update Posted: September 22, 2016