Atorvastatin Three Year Pediatric Study
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 6 - 15 |
| Updated: | 11/23/2013 |
| Start Date: | March 2009 |
| End Date: | October 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Three Year, Prospective, Open-Label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
The purpose of this study is to characterize three year descriptive growth and development
(ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction
in pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin
treatment.
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 potential who is not using adequate contraceptive measures or any
female who is pregnant or breastfeeding. Any female who becomes pregnant during study
participation will be immediately discontinued from treatment and counseled appropriately
about the in utero exposure.
Known hypersensitivities to HMG-CoA reductase inhibitors
We found this trial at
6
sites
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