8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia - Tabular View

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

Tracking Information

First Received Date ^†

August 21, 2008

Last Updated Date

April 28, 2009

Start Date ^†

December 2008

Current Primary Outcome Measures ^†

Population PK models for atorvastatin and its metabolites will be developed. Key parameters may include apparent clearance CL/F and/or apparent volume of distribution V/F of the plasma/central compartment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00739999 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Descriptive parameter: FMD assessments [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Safety laboratory tests, vital signs, and adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Change and % change from baseline in pharmacodynamic responses of LDL, TC, TG, HDL, VLDL, and Apo A-1, and Apo B [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Safety laboratory tests, vital signs, and adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Change and % change from baseline in pharmacodynamic responses of LDL, TC, TG, HDL, VLDL, and Apo A-1, and Apo B [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^†

8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

Official Title ^†

A 8-Week, Open-Label, Phase 1 Study To Evaluate Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

Brief Summary

To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Other, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study

Condition ^†

Hypercholesterolemia, Familial

Intervention ^†

Drug: Atorvastatin

Study Arms / Comparison Groups

Other: 6-17 years will be administered with atorvastatin with initial doses based on age cohort

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

Enrollment ^†

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Genetically confirmed HeFH with LDL greater or equal 4 mmol/L at baseline

Exclusion Criteria:

Evidence or history of clinically significant diseases, homozygous FH

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^†

Canada, Greece, Norway

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739999

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.