Atorvastatin Three Year Pediatric Study
Tracking Information
Start Date ICMJE | March 2009 |
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Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: July 29, 2009) |
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Original Primary Outcome Measures ICMJE (submitted: January 22, 2009) |
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Change History | Complete list of historical versions of study NCT00827606 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 29, 2009) | To estimate long-term, three year efficacy via the descriptive exploratory biomarker of Flow Mediated Dilation (FMD) in a subset of the HeFH pediatric subjects treated with atorvastatin in this study [ Time Frame: 3 monthly visits post treatment initiation, next visit 3 months later, then every 6 months for the r ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: January 22, 2009) | To estimate long-term, three year efficacy via the descriptive exploratory biomarker of Flow Mediated Dilation (FMD) in a subset of the HeFH pediatric subjects treated with atorvastatin in this study [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ] |
Descriptive Information
Brief Title ICMJE | Atorvastatin Three Year Pediatric Study |
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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 | |
Study Phase | Phase II, Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Familial Hypercholesterolemia |
Intervention ICMJE | Drug: atorvastatin Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years |
Study Arms / Comparison Groups | Atorvastatin: Experimental All subjects will be treated with atorvastatin Intervention: Drug: atorvastatin |
Recruitment Information
Estimated Enrollment ICMJE | 250 | ||||
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Estimated Completion Date | July 2013 | ||||
Estimated Primary Completion Date | July 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 | ||||
Gender | Both | ||||
Ages | 6 Years to 15 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Belgium, Canada, Greece, Hungary, Italy, Norway, Poland, Puerto Rico, Russian Federation, Slovakia, Spain, Turkey |
Administrative Information
NCT ID ICMJE | NCT00827606 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A2581173 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/