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Atorvastatin Three Year Pediatric Study

NCT00827606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2021-02-21

Study results available
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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.

Conditions

  • Familial Hypercholesterolemia

Interventions

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)

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Greece
  • Hungary
  • Italy
  • Norway
  • Poland
  • Puerto Rico
  • Russia
  • Slovakia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827606 on ClinicalTrials.gov