PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
- 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
- Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)
- Certain medical conditions and lab test results
- History of a reaction to rosuvastatin or other statin drugs
- Use of specified disallowed medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rosuva 10 Rosuvastatin rosuvastatin 10 mg rosuva 20 Rosuvastatin rosuvastatin 20 mg Placebo Placebo Placebo rosuva ol Rosuvastatin rosuvastatin open label rosuva 5 Rosuvastatin rosuvastatin 5 mg
- Primary Outcome Measures
Name Time Method Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase 12 weeks Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100
- Secondary Outcome Measures
Name Time Method 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 Treatment 12 weeks Percent of patients achieving LDL-C \< 110 mg/dL out of the total patients in each treatment group
Percent Change in HDL-C After 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 Weeks After 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-1 After 12 weeks of treatment Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment
Percent Change in LDL-C/HDL-C After 12 week of treatment Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment
Percent Change in TC/HDL-C After 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-C After 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