Atorvastatin Three Year Pediatric Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 21, 2009

Last Updated Date

May 3, 2009

Start Date ^†

March 2009

Current Primary Outcome Measures ^†

• To characterize long-term, three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) in pediatric subjects with HeFH receiving atorvastatin treatment [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]
• To characterize long-term, three year descriptive efficacy (LDL-C, TC, TG, HDL, VLDL, Apo A-1, Apo B), tolerability and safety in pediatric subjects with HeFH receiving atorvastatin treatment. [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

To characterize long-term, three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) in pediatric subjects with HeFH receiving atorvastatin treatment [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]
To characterize long-term, three year descriptive efficacy (LDL-C, TC, TG, HDL, VLDL, Apo A-1, Apo B), tolerability and safety in pediatric subjects with HeFH receiving atorvastatin treatment. [ Time Frame: 4 July 2013 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00827606 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

• 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Atorvastatin Three Year Pediatric Study

Official Title ^†

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

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 ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Familial Hypercholesterolemia

Intervention ^†

Drug: atorvastatin

Study Arms / Comparison Groups

Experimental: All subjects will be treated with atorvastatin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

250

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Hetrozygous 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

Gender

Both

Ages

6 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^†

United States, Canada, Puerto Rico

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00827606

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.