Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LIPITOR is indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization…
Also known as Atorvastatin
Lipitor · 7 trials · 5 indications
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Assessments were performed in the fasting state (minimum 10-hour fast).
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Assessments were performed in the fasting state (minimum 10-hour fast).
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Assessments were performed in the fasting state (minimum 10-hour fast).
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Assessments were performed in the fasting state (minimum 10-hour fast).
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Assessments were performed in the fasting state (minimum 10-hour fast).
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Assessments were performed in the fasting state (minimum 10-hour fast).
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Assessments were performed in the fasting state (minimum 10-hour fast).
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.
Investigator assessment of height changes during the study. Change from baseline was also determined.
Investigator assessment of height changes during the study.
Investigator assessment of height changes during the study. Change from baseline was also determined.
Investigator assessment of height changes during the study.
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Investigator assessment of weight changes during the study.
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Investigator assessment of weight changes during the study.
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Investigator assessment of BMI changes during the study.
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Investigator assessment of BMI changes during the study.
Investigator assessment of age during the study. Change from baseline was also determined.
Investigator assessment of age during the study.
Investigator assessment of age during the study. Change from baseline was also determined.
Investigator assessment of age 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.
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensitive, and specific high-performance liquid chromatography tandem mass spectrometric method. Data presented are the result of the model used.
Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromatography tandem mass spectrometric method. Vc/F value based on 70 kg body weight. Parameter estimation uncertainty (95% CI) by non-parametric bootstrap analysis. Data presented are result of model used.
| Arm | Type | Description |
|---|---|---|
| Atorvastatin | EXPERIMENTAL | All subjects will be treated with atorvastatin |
| 1 | OTHER | 6-10 years will be administered with atorvastatin tablet formulation with initial doses based on age cohort. |
| 2 | OTHER | 10-17 years will be administered 10-mg daily dose of atorvastatin tablet formulation. |
| Reference | OTHER | Commercial 10 mg Lipitor formulation tablet |
| Test | OTHER | Atorvastatin pediatric formulation |
| Name | Type | Description |
|---|---|---|
| atorvastatin | DRUG | Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily) |
| Lipitor | DRUG | A single dose of 10 mg Lipitor tablet |
| Atorvastatin pediatric formulation | DRUG | A single dose of 10 mg atorvastatin pediatric formulation |
| Atorvastatin pediatric appropriate formulation | DRUG | A single dose of pediatric appropriate atorvastatin 80 mg formulation |
Inclusion Criteria: * Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l Exclusion Criteria: * Active liver disease or hepatic dysfunction, or persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN). Female of childbearing ...
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