MedTrace Logo

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

NCT02226198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-07-04

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.

Conditions

  • Homozygous Familial Hypercholesterolemia (HoFH)

Interventions

DRUG

Rosuvastatin 20mg

Active drug will be taken taken orally, QD, either in the morning or in the evening

DRUG

Placebo

Will be taken taken orally, QD, either in the morning or in the evening

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Belgium
  • Canada
  • Denmark
  • Israel
  • Malaysia
  • Netherlands
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT02226198 on ClinicalTrials.gov