Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in LDL-C	At Month 3, Month 12 and Month 24	Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Primary	Sexual Maturation by Tanner Staging at Baseline	At Baseline	Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Primary	Single Dose PK - Cmax	Serial blood samples over 24 hours.	Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
Primary	Percent Change From Baseline in Height	At Month 12 and Month 24	One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Primary	Sexual Maturation by Tanner Staging at Month 12	At Baseline	Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Primary	Sexual Maturation by Tanner Staging at Month 24	At Baseline	Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Primary	Single Dose PK - Tmax	Serial blood samples over 24 hours	Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
Primary	Single Dose PK - AUC(0-24)	Serial blood samples over 24 hours	Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
Secondary	Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1	At Month 3, Month 12 and Month 24	One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Secondary	Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT)	At Month 12 and Month 24	One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Secondary	Adverse Events	2-year study period	Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Secondary	Total Duration of Exposure	2-year study period	Total duration of exposure was calculated as \[last dose date of rosuva - first dose date of rosuva + 1 day\]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Secondary	Overal Treatment Adherence	2-year study period	Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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