An study to evaluate rosuvastatin in children and adolescents with Familial Hypercholesterolaemia

Study identifier:D3561C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Efficacy and 2-Year Safety Study of Open-label Rosuvastatin in Children and Adolescents (aged from 6 to less than 18 years) with Familial Hypercholesterolaemia

Medical condition

Familial Hypercholesterolaemia

Phase

Phase 3

Healthy volunteers

No

Study drug

rosuvastatin calcium

Sex

All

Actual Enrollment

315

Study type

Interventional

Age

6 Years - 17 Years

Date

Study Start Date: 01 Feb 2010
Primary Completion Date: 01 Feb 2013
Study Completion Date: 01 Feb 2013

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria