MedTrace Logo

An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia

NCT01078675 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2015-04-07

Study results available
· View outcomes & findings →

Summary

This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients.

This study will also measure levels of drug in the blood and see how well it is tolerated. This is known as pharmacokinetic (PK) analysis.

At baseline only a small number of patients will participate in a single dose PK phase over 24 hours.

In order to see if this medication works, a control group of healthy siblings will help the researchers to compare certain results.

Conditions

  • Familial Hypercholesterolaemia

Interventions

DRUG

rosuvastatin calcium

5 mg, oral, once daily, 24 months

DRUG

rosuvastatin calcium

10 mg, oral, once daily, 24 months

DRUG

rosuvastatin calcium

20 mg, oral, once daily, 24 months

Sponsors & Collaborators

Principal Investigators

  • John J.P. Kastelein, MD, PhD · Chairman, Dept. of Vascular Medicine, Academic Medical Center, Meibergdreef 9

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Belgium
  • Canada
  • Netherlands
  • Norway

Study Locations

More Related Trials

Entities

Companies

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 NCT01078675 on ClinicalTrials.gov