EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

Research Site

Research SIte

A phase IIIb, efficacy, and safety study of rosuvastatin in children 10-17 years of age with heterozygous familial hypercholesterolemia: a 12-week, double-blind, randomized, multicenter, placebo-controlled study with a 40-week, open-label, follow-up

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

Age Continuous

Gender, Male/Female

Baseline low-density lipoprotein cholesterol (LDL-C)

Study Specific Characteristic

Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed.  Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.

Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day 0) to the end of the 12-week double-blind treatment phase

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

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)

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

Percent control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment

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

Percent change in HDL-C

Percent change in Non-HDL-C at 12 weeks

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

Percent change in triglycerides (TG)

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

Percent change in total cholesterol (TC)

Percent change in ApoA-1 after 12 weeks of treatment

Percent change in apolipoprotein A-1 (ApoA-1)

Percent change in ApoB after 12 weeks of treatment

Percent change in apolipoprotein B (ApoB)

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

Percent change in ApoB/ApoA-1

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

Percent change in LDL-C/HDL-C

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

Percent change in TC/HDL-C

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

Percent change in non-HDL-C/HDL-C

Randomized Double Blind Period

40-week rosuvastatin open label period

Patients entered a 6 week dietary lead-in/drug washout period. Eligible patients were then randomly assigned to double-blind treatment with rosuvastatin 5 mg, 10 mg, 20 mg, or matching placebo, administered orally once daily for 12 weeks.

Arms	Assigned Interventions
Active Comparator: rosuva 5 rosuvastatin 5 mg	Drug: Rosuvastatin oral Other Name: Nexium
Active Comparator: rosuva 10 rosuvastatin 10 mg	Drug: Rosuvastatin oral Other Name: Nexium
Active Comparator: rosuva 20 rosuvastatin 20 mg	Drug: Rosuvastatin oral Other Name: Nexium
Placebo Comparator: Placebo Placebo	Drug: Placebo oral
Other: rosuva ol rosuvastatin open label	Drug: Rosuvastatin oral Other Name: Nexium

PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin

Official Title

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Study design

Verification:

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=323&filename=CSR-D3561C00087.pdf

CSR-D3561C00087.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator