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Adult Trials: 18+ Years
- Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Atorvastatin Three Year Pediatric Study | |||
| Official Title ICMJE | A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Familial Hypercholesterolemia | |||
| Intervention ICMJE | Drug: atorvastatin
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) | |||
| Study Arms ICMJE | Experimental: Atorvastatin
All subjects will be treated with atorvastatin Intervention: Drug: atorvastatin | |||
| Publications * | Langslet G, Breazna A, Drogari E. A 3-year study of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2016 Sep-Oct;10(5):1153-1162.e3. doi: 10.1016/j.jacl.2016.05.010. Epub 2016 Jun 7. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 272 | |||
| Original Estimated Enrollment ICMJE | 250 | |||
| Actual Study Completion Date ICMJE | October 2013 | |||
| Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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 | |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 6 Years to 15 Years (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Belgium, Canada, Germany, Greece, Hungary, Italy, Norway, Poland, Puerto Rico, Russian Federation, Slovakia, Spain, Switzerland, Turkey, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00827606 | |||
| Other Study ID Numbers ICMJE | A2581173 2008-006130-95 ( EudraCT Number ) | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||