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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
173
oral
oral
Research Site
Los Angeles, California, United States
Research Site
Hyde Park, New York, United States
Research Site
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 in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100
Time frame: 12 weeks
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 change from baseline in LDL-C after six week of treatment
Time frame: 6 weeks
Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment
Percent of patients achieving LDL-C \< 110 mg/dL out of the total patients in each treatment group
Time frame: 12 weeks
Percent Change in HDL-C
Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment
Time frame: After 12 weeks of treatment
Percent Change in Non-HDL-C at 12 Weeks
Percent change in non-HDL-C at 12 weeks
Time frame: After 12 weeks of treatment
Percent Change in Triglycerides (TG)
Percent change in tryglycerides (TG) after 12 weeks of treatment
Time frame: After 12 weeks of treatment
Percent Change in Total Cholesterol (TC)
Percent change from baseline in total cholesteral after 12 weeks of treatment
Time frame: After 12 weeks of treatment
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Cincinnati, Ohio, United States
Research Site
Wexford, Pennsylvania, United States
Research Site
Hamilton, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Laval, Quebec, Canada
Research Site
Sherbrook, Quebec, Canada
Research SIte
Amsterdam, Netherlands
...and 10 more locations
Percent Change in Apolipoprotein A-1 (ApoA-1)
Percent change in ApoA-1 after 12 weeks of treatment
Time frame: After 12 weeks of treatment
Percent Change in Apolipoprotein B (ApoB)
Percent change in ApoB after 12 weeks of treatment
Time frame: After 12 weeks of treatment
Percent Change in ApoB/ApoA-1
Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment
Time frame: After 12 weeks of treatment
Percent Change in LDL-C/HDL-C
Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment
Time frame: After 12 week of treatment
Percent Change in TC/HDL-C
Percent change in the ratio of TC/HDL-C after 12 weeks of treatment
Time frame: After 12 weeks of treatment
Percent Change in Non-HDL-C/HDL-C
Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment
Time frame: After 12 weeks of treatment