PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Familial Hypercholesterolemia

Treatments: Drug: Rosuvastatin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00355615

PLUTO

D3561C00087

Details and patient eligibility

About

The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.

Enrollment: 173 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)

Exclusion criteria

• Certain medical conditions and lab test results
• History of a reaction to rosuvastatin or other statin drugs
• Use of specified disallowed medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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173 participants in 5 patient groups, including a placebo group

rosuva 5

Active Comparator group

Description:

rosuvastatin 5 mg

Treatment:

Drug: Rosuvastatin

rosuva 10

Active Comparator group

Description:

rosuvastatin 10 mg

Treatment:

Drug: Rosuvastatin

rosuva 20

Active Comparator group

Description:

rosuvastatin 20 mg

Treatment:

Drug: Rosuvastatin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

rosuva ol

Other group

Description:

rosuvastatin open label

Treatment:

Drug: Rosuvastatin