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PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

Phase 3
Completed
Conditions
Familial Hypercholesterolemia
Interventions
Drug: Rosuvastatin
Drug: Placebo
Registration Number
NCT00355615
Lead Sponsor
AstraZeneca
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
173
Inclusion Criteria
  • Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)
Read More
Exclusion Criteria
  • Certain medical conditions and lab test results
  • History of a reaction to rosuvastatin or other statin drugs
  • Use of specified disallowed medications
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
rosuva 10Rosuvastatinrosuvastatin 10 mg
rosuva 20Rosuvastatinrosuvastatin 20 mg
PlaceboPlaceboPlacebo
rosuva olRosuvastatinrosuvastatin open label
rosuva 5Rosuvastatinrosuvastatin 5 mg
Primary Outcome Measures
NameTimeMethod
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase12 weeks

Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100

Secondary Outcome Measures
NameTimeMethod
Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12)6 weeks

Percent change from baseline in LDL-C after six week of treatment

Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment12 weeks

Percent of patients achieving LDL-C \< 110 mg/dL out of the total patients in each treatment group

Percent Change in HDL-CAfter 12 weeks of treatment

Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment

Percent Change in Non-HDL-C at 12 WeeksAfter 12 weeks of treatment

Percent change in non-HDL-C at 12 weeks

Percent Change in Triglycerides (TG)After 12 weeks of treatment

Percent change in tryglycerides (TG) after 12 weeks of treatment

Percent Change in Total Cholesterol (TC)After 12 weeks of treatment

Percent change from baseline in total cholesteral after 12 weeks of treatment

Percent Change in Apolipoprotein A-1 (ApoA-1)After 12 weeks of treatment

Percent change in ApoA-1 after 12 weeks of treatment

Percent Change in Apolipoprotein B (ApoB)After 12 weeks of treatment

Percent change in ApoB after 12 weeks of treatment

Percent Change in ApoB/ApoA-1After 12 weeks of treatment

Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment

Percent Change in LDL-C/HDL-CAfter 12 week of treatment

Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment

Percent Change in TC/HDL-CAfter 12 weeks of treatment

Percent change in the ratio of TC/HDL-C after 12 weeks of treatment

Percent Change in Non-HDL-C/HDL-CAfter 12 weeks of treatment

Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment

Trial Locations

Locations (2)

Research Site

🇪🇸

Reus, Spain

Research SIte

🇳🇱

Waalwijk, Netherlands

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