Phase 3
Completed N=177
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
Source: ClinicalTrials.gov NCT00355615 ↗Enrolled (actual)
177
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase — -38.5; -44.4; -50.2; -0.5 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase |
-38.5; -44.4; -50.2; -0.5 | — |
| SECONDARY 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) |
-40.3; -45.2; -50.0; -0.6 | — |
| SECONDARY Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment |
11.9; 40.9; 40.9; 0.0 | — |
| SECONDARY Percent Change in HDL-C |
4.5; 10.1; 8.9; 7.6 | — |
| SECONDARY Percent Change in Non-HDL-C at 12 Weeks |
-36.3; -42.8; -47.7; -0.8 | — |
| SECONDARY Percent Change in Triglycerides (TG) |
2.6; -14.2; -7.9; 3.4 | — |
| SECONDARY Percent Change in Total Cholesterol (TC) |
-30.0; -34.1; -38.9; 0.2 | — |
| SECONDARY Percent Change in Apolipoprotein A-1 (ApoA-1) |
2.3; 4.3; 3.9; 3.6 | — |
| SECONDARY Percent Change in Apolipoprotein B (ApoB) |
-32.1; -37.8; -40.7; -1.5 | — |
| SECONDARY Percent Change in ApoB/ApoA-1 |
-33.1; -40.0; -42.8; -3.4 | — |
| SECONDARY Percent Change in LDL-C/HDL-C |
-40.4; -48.6; -53.6; -5.5 | — |
| SECONDARY Percent Change in TC/HDL-C |
-32.1; -39.3; -43.2; -5.2 | — |
| SECONDARY Percent Change in Non-HDL-C/HDL-C |
-37.9; -47.1; -51.2; -5.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00355615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.