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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Familial Hypercholesterolaemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

rosuvastatin calcium

Intervention Type DRUG

5 mg, oral, once daily, 24 months

rosuvastatin calcium

Intervention Type DRUG

10 mg, oral, once daily, 24 months

rosuvastatin calcium

Intervention Type DRUG

20 mg, oral, once daily, 24 months

Interventions

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rosuvastatin calcium

5 mg, oral, once daily, 24 months

Intervention Type DRUG

rosuvastatin calcium

10 mg, oral, once daily, 24 months

Intervention Type DRUG

rosuvastatin calcium

20 mg, oral, once daily, 24 months

Intervention Type DRUG

Other Intervention Names

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Crestor Crestor Crestor

Eligibility Criteria

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Inclusion Criteria

* children and adolescents (aged 6 to less than 18 years) with Familial Hypercholesterolaemia
* Patients aged between 6 and less than 10 years of age must not be taking a statin medicine

Exclusion Criteria

* History of muscle or sensitivity reactions to any statin medicines
* Current active liver disease or dysfunction (except a confirmed diagnosis of Gilbert's disease)

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No