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A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

A Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to <18 Years) With Homozygous Familial Hypercholesterolemia (HoFH)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02226198
Acronym
HYDRA
Enrollment
20
Registered
2014-08-27
Start date
2014-11-30
Completion date
2015-07-31
Last updated
2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homozygous Familial Hypercholesterolemia (HoFH)

Keywords

LDL-C, HoFH, Hyperlipidemia

Brief summary

The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.

Detailed description

This is a randomized, double-blind, placebo-controlled, multi-center, cross-over study of the efficacy, safety and tolerability rosuvastatin in children and adolescents (aged 6 to \<18 years) with homozygous familial hypercholesterolemia (HoFH). The study is designed to assess the efficacy of rosuvastatin 20 mg compared to placebo on lipids, lipoproteins and apolipoproteins in pediatric patients with HoFH. The outcome measures to be assessed include low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, apolipoprotein B (ApoB), apolipoprotein A 1 (ApoA-1) and ApoB/ApoA-1 following 6 weeks of treatment with rosuvastatin 20 mg or placebo. Pharmacokinetic data of the trough plasma exposure of rosuvastatin will also be assessed in these pediatric patients with HoFH.

Interventions

DRUGRosuvastatin 20mg

Active drug will be taken taken orally, QD, either in the morning or in the evening

DRUGPlacebo

Will be taken taken orally, QD, either in the morning or in the evening

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

1. Prior to any study related procedures being performed, provision of written informed consent from a parent/both parents or guardian and statement of assent from the child or adolescent (if required by Institutional Review Board \[IRB\] or Independent Ethics Committee \[EC\] according to local regulations and guidelines). Communication between the Investigator, patient/guardian and child/adolescent to confirm understanding and required compliance with the requirements of the study. 2. Male and female children and adolescents (aged 6 to \<18 years) with at least 1 of the following criteria: Documentation of genetic testing confirming 2 mutated alleles of the LDL receptor gene locus; and/or Documented untreated LDL C \>500 mg/dL (12.9 mmol/L) and triglyceride (TG) \<300 mg/dL (3.4 mmol/L) and at least 1 of the following criteria: 1. Tendinous and/or cutaneous xanthoma prior to 10 years of age; or 2. Documentation of HoFH in both parents by: * genetic and/or * clinical criteria 3. Negative pregnancy test (b human chorionic gonadotropin analysis) prior to baseline in females of child bearing potential: * Female patients of child bearing potential must adhere to a pregnancy prevention method (abstinence, chemical, or mechanical) during the study and 3 months following the last dose. * Male patients should refrain from fathering a child (including sperm donation) during the study and up to 3 months following the last dose; and 4. Willing to follow all study procedures including adherence to dietary guidelines, study visits, fasting blood draws, and compliance with study treatment regimens.

Exclusion criteria

1. History of statin inducted myopathy or serious hypersensitivity reaction to other HMG CoA reductase inhibitors (statins), including rosuvastatin, at Visit 1. 2. Fasting serum glucose of \>9.99 mmol/L (180 mg/dL) or glycosylated hemoglobin \>9% at Visit 1 or patients with a history of diabetic ketoacidosis within the past year. 3. Uncontrolled hypothyroidism defined as thyroid stimulating hormone (TSH) \>1.5 times the upper limit of normal (ULN) at Visit 1 or patients whose thyroid replacement therapy was initiated or modified within the last 3 months prior to Visit 2. 4. Current active liver disease or hepatic dysfunction (except a confirmed diagnosis of Gilbert's disease) as defined as elevations of 1.5 times the upper limit of normal (ULN) for any age in any of the following liver function tests at Visit 1: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or bilirubin. 5. Definite or suspected personal history or family history of clinically significant adverse drug reactions (ADRs), or hypersensitivity to drugs with a similar chemical structure to rosuvastatin as well as other statins.

Design outcomes

Primary

MeasureTime frameDescription
LDL-Cholesterol (mg/dL)Samples taken on Day 42 (week 6) and on day 84 (week 12)Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment
LDL-Cholesterol (mmol/L)Samples taken on Day 42 (week 6) and on day 84 (week 12)Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment

Secondary

MeasureTime frameDescription
TC (mmol/L)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of total cholesterol (TC)
Non-HDL C (mg/dL)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)
Non-HDL C (mmol/L)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)
ApoB (mg/dL)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of apolipoprotein B (ApoB)
ApoB (g/L)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of apolipoprotein B (ApoB)
HDL-C (mg/dL)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of high density lipoprotein cholesterol (HDL C)
HDL-C (mmol/L)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of high density lipoprotein cholesterol (HDL C)
LDL-C, Not on Apheresis (mg/dL)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis
LDL-C, Not on Apheresis (mmol/L)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis
LDL-C From End of Placebo (mg/dL)Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg
LDL-C From End of Placebo (mmol/L)Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg
Trough ConcentrationsSamples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.
Adverse EventsFrom screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)Safety and tolerability will be described in terms of frequency and severity of adverse events
AE's Leading to DiscontinuationFrom screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)Safety and tolerability will be described in terms of rate of discontinuations due to adverse events
TC (mg/dL)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of total cholesterol (TC)
HeightWeek 0 (start of cross-over), weeks 6, week 12 and week 18Safety and tolerability will be described in terms of growth, including height (linear growth \[cm and standard deviation (SD) score\]), and weight.
Height Z-scoreWeek 0 (start of cross-over), weeks 6, week 12 and week 18Safety and tolerability will be described in terms of growth, including height (linear growth \[cm and standard deviation (SD) score\]), and weight.
WeightWeek 0 (start of cross-over), weeks 6, week 12 and week 18Safety and tolerability will be described in terms of growth, including height (linear growth \[cm and standard deviation (SD) score\]), and weight.
Tanner StageWeek 0 (start of cross-over)Stages for fem (Pubic hair, Breasts): 1. (Preadol,Preadol) 2. (Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr) 3. (Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation) 4. (Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound) 5. (Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes) 1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred.
TG (mg/dL)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of triglycerides (TG)
ECG AbnormalitiesWeek 0Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)
TG (mmol/L)Samples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of triglycerides (TG)
LDL C/HDL CSamples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)
TC/HDL CSamples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)
Non-HDL C/HDL CSamples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C
ApoB/ApoASamples taken at Day 42 (week 6) and Day 84 (week 12)Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)
Physical Exam AbnormalititesScreening, Week 0, week 6, week 12 and week 18, week 24Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.
Abnormal Vital SignsFrom screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)Safety and tolerability will be described in terms of abnormal vital signs
Abnormal Serum LevelsFrom screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found
Urinalysis AbnormalititesWeek 0, week 6, week 12 and week 18Safety and tolerability will be described in terms of abnormal urine laboratory values

Countries

Belgium, Canada, Denmark, Israel, Malaysia, Netherlands, Taiwan

Participant flow

Recruitment details

Twenty HoFH patients were recruited to 9 centers within 8 countries (Belgium, Canada, Denmark, Israel, Malaysia, Sweden, Taiwan, and The Netherlands) that participated in the study. FSI date: 03-Nov-2014

Pre-assignment details

20 enrolled, 3 withdrew consent, 3 did not fulfil eligibility criteria. Among the 14 left, ten went through 4 week lead-in phase and 4 did not.

Participants by arm

ArmCount
Cross-over
Cross-over phase
14
Total14

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Cross-Over: First Intervention (6 Weeks)No possibility to draw blood010
Lead-in PhaseProtocol Violation100

Baseline characteristics

CharacteristicCross-over
Age, Continuous10.9 Years
STANDARD_DEVIATION 2.7
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
4 / 114 / 141 / 13
serious
Total, serious adverse events
0 / 110 / 140 / 13

Outcome results

Primary

LDL-Cholesterol (mg/dL)

Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment

Time frame: Samples taken on Day 42 (week 6) and on day 84 (week 12)

Population: 6-17 years HoFH

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinLDL-Cholesterol (mg/dL)396.0 mg/dLStandard Deviation 195.99
C-FAS PlaceboLDL-Cholesterol (mg/dL)481.4 mg/dLStandard Deviation 184.9
Comparison: cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% deltap-value: 0.00595% CI: [-33.5, -9.1]Mixed Models Analysis
Primary

LDL-Cholesterol (mmol/L)

Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment

Time frame: Samples taken on Day 42 (week 6) and on day 84 (week 12)

Population: 6-17 years HoFH

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinLDL-Cholesterol (mmol/L)10.26 mmol/LStandard Deviation 5.076
C-FAS PlaceboLDL-Cholesterol (mmol/L)12.47 mmol/LStandard Deviation 4.79
Comparison: cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% deltap-value: 0.00595% CI: [-33.5, -9.1]Mixed Models Analysis
Secondary

Abnormal Serum Levels

Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found

Time frame: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)

ArmMeasureGroupValue (NUMBER)
C-FAS RosuvastatinAbnormal Serum LevelsLymphocytes/Leukocytes week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsCreatine Kinase week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsHematocrit week 181 participants
C-FAS RosuvastatinAbnormal Serum LevelsBicarbonate week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsBlood Urea Nitrogen week 61 participants
C-FAS RosuvastatinAbnormal Serum LevelsCreatine Kinase week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils/Leukocytes week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsPlatelets week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsLymphocytes/Leukocytes week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsGlucose week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsUrate week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsPlatelets week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Volume week 241 participants
C-FAS RosuvastatinAbnormal Serum LevelsGlucose week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsHemoglobin week 02 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlbumin week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsLymphocytes/Leukocytes week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 181 participants
C-FAS RosuvastatinAbnormal Serum LevelsGlucose week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsUrate week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlanine Aminotransferase week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsBlood Urea Nitrogen week 01 participants
C-FAS RosuvastatinAbnormal Serum LevelsGlucose week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Volume week 121 participants
C-FAS RosuvastatinAbnormal Serum LevelsPlatelets week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsLymphocytes/Leukocytes week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsGlucose week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 02 participants
C-FAS RosuvastatinAbnormal Serum LevelsChloride week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsErythrocytes week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsPotassium week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 241 participants
C-FAS RosuvastatinAbnormal Serum LevelsBlood Urea Nitrogen week 121 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 122 participants
C-FAS RosuvastatinAbnormal Serum LevelsHemoglobin week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsProtein week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsProtein week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlbumin week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlbumin week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Volume week 181 participants
C-FAS RosuvastatinAbnormal Serum LevelsProtein week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsBicarbonate week 241 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 242 participants
C-FAS RosuvastatinAbnormal Serum LevelsHemoglobin week 181 participants
C-FAS RosuvastatinAbnormal Serum LevelsProtein week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlanine Aminotransferase week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsPotassium week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsBlood Urea Nitrogen week 181 participants
C-FAS RosuvastatinAbnormal Serum LevelsProtein week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsErythrocytes week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils/Leukocytes week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsSodium week 02 participants
C-FAS RosuvastatinAbnormal Serum LevelsBlood Urea Nitrogen week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlbumin week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsHemoglobin week 121 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Volume week 61 participants
C-FAS RosuvastatinAbnormal Serum LevelsPotassium week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsChloride week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsSodium week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils/Leukocytes week 61 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlanine Aminotransferase week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsHemoglobin week 62 participants
C-FAS RosuvastatinAbnormal Serum LevelsSodium week 183 participants
C-FAS RosuvastatinAbnormal Serum LevelsPlatelets week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils/Leukocytes week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsBicarbonate week 01 participants
C-FAS RosuvastatinAbnormal Serum LevelsSodium week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsChloride week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsChloride week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsHematocrit week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsTotal Bilirubin week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlanine Aminotransferase week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsChloride week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsErythrocytes week 01 participants
C-FAS RosuvastatinAbnormal Serum LevelsTotal Bilirubin week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsPotassium week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 181 participants
C-FAS RosuvastatinAbnormal Serum LevelsCreatine Kinase week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsTotal Bilirubin week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlanine Aminotransferase week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsBicarbonate week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsHematocrit week 121 participants
C-FAS RosuvastatinAbnormal Serum LevelsTotal Bilirubin week 180 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Volume week 01 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsCreatine Kinase week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsTotal Bilirubin week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsPotassium week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsErythrocytes week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsHematocrit week 62 participants
C-FAS RosuvastatinAbnormal Serum LevelsUrate week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsSodium week 61 participants
C-FAS RosuvastatinAbnormal Serum LevelsNeutrophils/Leukocytes week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsCreatine Kinase week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsUrate week 60 participants
C-FAS RosuvastatinAbnormal Serum LevelsHematocrit week 02 participants
C-FAS RosuvastatinAbnormal Serum LevelsUrate week 120 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 241 participants
C-FAS RosuvastatinAbnormal Serum LevelsBicarbonate week 121 participants
C-FAS RosuvastatinAbnormal Serum LevelsLymphocytes/Leukocytes week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 123 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 01 participants
C-FAS RosuvastatinAbnormal Serum LevelsAlbumin week 00 participants
C-FAS RosuvastatinAbnormal Serum LevelsErythrocytes week 240 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 181 participants
C-FAS RosuvastatinAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 61 participants
C-FAS RosuvastatinAbnormal Serum LevelsPlatelets week 180 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 60 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Volume week 120 participants
C-FAS PlaceboAbnormal Serum LevelsErythrocytes week 180 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Volume week 180 participants
C-FAS PlaceboAbnormal Serum LevelsBicarbonate week 180 participants
C-FAS PlaceboAbnormal Serum LevelsErythrocytes week 120 participants
C-FAS PlaceboAbnormal Serum LevelsErythrocytes week 60 participants
C-FAS PlaceboAbnormal Serum LevelsHemoglobin week 00 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils/Leukocytes week 00 participants
C-FAS PlaceboAbnormal Serum LevelsBicarbonate week 240 participants
C-FAS PlaceboAbnormal Serum LevelsErythrocytes week 00 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 180 participants
C-FAS PlaceboAbnormal Serum LevelsAlanine Aminotransferase week 120 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Volume week 240 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils/Leukocytes week 180 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils/Leukocytes week 240 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Volume week 60 participants
C-FAS PlaceboAbnormal Serum LevelsAlbumin week 120 participants
C-FAS PlaceboAbnormal Serum LevelsBlood Urea Nitrogen week 180 participants
C-FAS PlaceboAbnormal Serum LevelsPotassium week 60 participants
C-FAS PlaceboAbnormal Serum LevelsBlood Urea Nitrogen week 00 participants
C-FAS PlaceboAbnormal Serum LevelsPotassium week 120 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Volume week 00 participants
C-FAS PlaceboAbnormal Serum LevelsPotassium week 180 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 240 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 240 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 00 participants
C-FAS PlaceboAbnormal Serum LevelsUrate week 121 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 180 participants
C-FAS PlaceboAbnormal Serum LevelsUrate week 181 participants
C-FAS PlaceboAbnormal Serum LevelsBlood Urea Nitrogen week 60 participants
C-FAS PlaceboAbnormal Serum LevelsUrate week 241 participants
C-FAS PlaceboAbnormal Serum LevelsPlatelets week 120 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 120 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 00 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 180 participants
C-FAS PlaceboAbnormal Serum LevelsBlood Urea Nitrogen week 120 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 240 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 120 participants
C-FAS PlaceboAbnormal Serum LevelsAlanine Aminotransferase week 180 participants
C-FAS PlaceboAbnormal Serum LevelsBlood Urea Nitrogen week 240 participants
C-FAS PlaceboAbnormal Serum LevelsChloride week 181 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 60 participants
C-FAS PlaceboAbnormal Serum LevelsChloride week 02 participants
C-FAS PlaceboAbnormal Serum LevelsChloride week 60 participants
C-FAS PlaceboAbnormal Serum LevelsChloride week 240 participants
C-FAS PlaceboAbnormal Serum LevelsAlanine Aminotransferase week 241 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 00 participants
C-FAS PlaceboAbnormal Serum LevelsCreatine Kinase week 00 participants
C-FAS PlaceboAbnormal Serum LevelsChloride week 120 participants
C-FAS PlaceboAbnormal Serum LevelsCreatine Kinase week 61 participants
C-FAS PlaceboAbnormal Serum LevelsPlatelets week 60 participants
C-FAS PlaceboAbnormal Serum LevelsLymphocytes/Leukocytes week 241 participants
C-FAS PlaceboAbnormal Serum LevelsCreatine Kinase week 120 participants
C-FAS PlaceboAbnormal Serum LevelsLymphocytes/Leukocytes week 181 participants
C-FAS PlaceboAbnormal Serum LevelsCreatine Kinase week 180 participants
C-FAS PlaceboAbnormal Serum LevelsAlbumin week 00 participants
C-FAS PlaceboAbnormal Serum LevelsLymphocytes/Leukocytes week 120 participants
C-FAS PlaceboAbnormal Serum LevelsCreatine Kinase week 241 participants
C-FAS PlaceboAbnormal Serum LevelsGlucose week 01 participants
C-FAS PlaceboAbnormal Serum LevelsLymphocytes/Leukocytes week 60 participants
C-FAS PlaceboAbnormal Serum LevelsGlucose week 60 participants
C-FAS PlaceboAbnormal Serum LevelsAlbumin week 60 participants
C-FAS PlaceboAbnormal Serum LevelsGlucose week 120 participants
C-FAS PlaceboAbnormal Serum LevelsLymphocytes/Leukocytes week 00 participants
C-FAS PlaceboAbnormal Serum LevelsGlucose week 181 participants
C-FAS PlaceboAbnormal Serum LevelsAlanine Aminotransferase week 00 participants
C-FAS PlaceboAbnormal Serum LevelsGlucose week 240 participants
C-FAS PlaceboAbnormal Serum LevelsHemoglobin week 240 participants
C-FAS PlaceboAbnormal Serum LevelsPotassium week 00 participants
C-FAS PlaceboAbnormal Serum LevelsPotassium week 240 participants
C-FAS PlaceboAbnormal Serum LevelsPlatelets week 01 participants
C-FAS PlaceboAbnormal Serum LevelsProtein week 00 participants
C-FAS PlaceboAbnormal Serum LevelsProtein week 60 participants
C-FAS PlaceboAbnormal Serum LevelsHemoglobin week 180 participants
C-FAS PlaceboAbnormal Serum LevelsProtein week 120 participants
C-FAS PlaceboAbnormal Serum LevelsAlbumin week 180 participants
C-FAS PlaceboAbnormal Serum LevelsProtein week 180 participants
C-FAS PlaceboAbnormal Serum LevelsPlatelets week 180 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils/Leukocytes week 60 participants
C-FAS PlaceboAbnormal Serum LevelsProtein week 240 participants
C-FAS PlaceboAbnormal Serum LevelsHemoglobin week 120 participants
C-FAS PlaceboAbnormal Serum LevelsSodium week 00 participants
C-FAS PlaceboAbnormal Serum LevelsUrate week 61 participants
C-FAS PlaceboAbnormal Serum LevelsSodium week 60 participants
C-FAS PlaceboAbnormal Serum LevelsAlbumin week 240 participants
C-FAS PlaceboAbnormal Serum LevelsHemoglobin week 60 participants
C-FAS PlaceboAbnormal Serum LevelsSodium week 120 participants
C-FAS PlaceboAbnormal Serum LevelsSodium week 180 participants
C-FAS PlaceboAbnormal Serum LevelsHematocrit week 240 participants
C-FAS PlaceboAbnormal Serum LevelsSodium week 240 participants
C-FAS PlaceboAbnormal Serum LevelsBicarbonate week 00 participants
C-FAS PlaceboAbnormal Serum LevelsTotal Bilirubin week 00 participants
C-FAS PlaceboAbnormal Serum LevelsAlanine Aminotransferase week 61 participants
C-FAS PlaceboAbnormal Serum LevelsHematocrit week 180 participants
C-FAS PlaceboAbnormal Serum LevelsTotal Bilirubin week 61 participants
C-FAS PlaceboAbnormal Serum LevelsNeutrophils/Leukocytes week 120 participants
C-FAS PlaceboAbnormal Serum LevelsHematocrit week 120 participants
C-FAS PlaceboAbnormal Serum LevelsTotal Bilirubin week 120 participants
C-FAS PlaceboAbnormal Serum LevelsTotal Bilirubin week 180 participants
C-FAS PlaceboAbnormal Serum LevelsBicarbonate week 60 participants
C-FAS PlaceboAbnormal Serum LevelsHematocrit week 60 participants
C-FAS PlaceboAbnormal Serum LevelsTotal Bilirubin week 240 participants
C-FAS PlaceboAbnormal Serum LevelsPlatelets week 240 participants
C-FAS PlaceboAbnormal Serum LevelsUrate week 01 participants
C-FAS PlaceboAbnormal Serum LevelsHematocrit week 00 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 60 participants
C-FAS PlaceboAbnormal Serum LevelsErythrocytes week 242 participants
C-FAS PlaceboAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 120 participants
C-FAS PlaceboAbnormal Serum LevelsBicarbonate week 120 participants
MaintenanceAbnormal Serum LevelsErythrocytes week 60 participants
MaintenanceAbnormal Serum LevelsChloride week 120 participants
MaintenanceAbnormal Serum LevelsChloride week 180 participants
MaintenanceAbnormal Serum LevelsAlanine Aminotransferase week 00 participants
MaintenanceAbnormal Serum LevelsAlanine Aminotransferase week 60 participants
MaintenanceAbnormal Serum LevelsAlanine Aminotransferase week 120 participants
MaintenanceAbnormal Serum LevelsAlanine Aminotransferase week 180 participants
MaintenanceAbnormal Serum LevelsAlanine Aminotransferase week 240 participants
MaintenanceAbnormal Serum LevelsAlbumin week 00 participants
MaintenanceAbnormal Serum LevelsAlbumin week 60 participants
MaintenanceAbnormal Serum LevelsPotassium week 00 participants
MaintenanceAbnormal Serum LevelsAlbumin week 120 participants
MaintenanceAbnormal Serum LevelsAlbumin week 180 participants
MaintenanceAbnormal Serum LevelsAlbumin week 240 participants
MaintenanceAbnormal Serum LevelsBicarbonate week 00 participants
MaintenanceAbnormal Serum LevelsBicarbonate week 61 participants
MaintenanceAbnormal Serum LevelsBicarbonate week 121 participants
MaintenanceAbnormal Serum LevelsBicarbonate week 181 participants
MaintenanceAbnormal Serum LevelsBicarbonate week 241 participants
MaintenanceAbnormal Serum LevelsBlood Urea Nitrogen week 00 participants
MaintenanceAbnormal Serum LevelsBlood Urea Nitrogen week 60 participants
MaintenanceAbnormal Serum LevelsBlood Urea Nitrogen week 120 participants
MaintenanceAbnormal Serum LevelsBlood Urea Nitrogen week 180 participants
MaintenanceAbnormal Serum LevelsBlood Urea Nitrogen week 240 participants
MaintenanceAbnormal Serum LevelsChloride week 00 participants
MaintenanceAbnormal Serum LevelsChloride week 60 participants
MaintenanceAbnormal Serum LevelsChloride week 240 participants
MaintenanceAbnormal Serum LevelsCreatine Kinase week 00 participants
MaintenanceAbnormal Serum LevelsCreatine Kinase week 60 participants
MaintenanceAbnormal Serum LevelsCreatine Kinase week 120 participants
MaintenanceAbnormal Serum LevelsCreatine Kinase week 180 participants
MaintenanceAbnormal Serum LevelsCreatine Kinase week 240 participants
MaintenanceAbnormal Serum LevelsGlucose week 00 participants
MaintenanceAbnormal Serum LevelsGlucose week 60 participants
MaintenanceAbnormal Serum LevelsProtein week 00 participants
MaintenanceAbnormal Serum LevelsGlucose week 120 participants
MaintenanceAbnormal Serum LevelsGlucose week 180 participants
MaintenanceAbnormal Serum LevelsGlucose week 240 participants
MaintenanceAbnormal Serum LevelsPotassium week 240 participants
MaintenanceAbnormal Serum LevelsProtein week 60 participants
MaintenanceAbnormal Serum LevelsProtein week 120 participants
MaintenanceAbnormal Serum LevelsProtein week 180 participants
MaintenanceAbnormal Serum LevelsProtein week 240 participants
MaintenanceAbnormal Serum LevelsSodium week 00 participants
MaintenanceAbnormal Serum LevelsSodium week 60 participants
MaintenanceAbnormal Serum LevelsSodium week 120 participants
MaintenanceAbnormal Serum LevelsSodium week 181 participants
MaintenanceAbnormal Serum LevelsUrate week 60 participants
MaintenanceAbnormal Serum LevelsSodium week 242 participants
MaintenanceAbnormal Serum LevelsTotal Bilirubin week 00 participants
MaintenanceAbnormal Serum LevelsTotal Bilirubin week 60 participants
MaintenanceAbnormal Serum LevelsTotal Bilirubin week 120 participants
MaintenanceAbnormal Serum LevelsTotal Bilirubin week 180 participants
MaintenanceAbnormal Serum LevelsTotal Bilirubin week 240 participants
MaintenanceAbnormal Serum LevelsUrate week 00 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 62 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 122 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 62 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Volume week 122 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Volume week 182 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Volume week 242 participants
MaintenanceAbnormal Serum LevelsHematocrit week 122 participants
MaintenanceAbnormal Serum LevelsHemoglobin week 03 participants
MaintenanceAbnormal Serum LevelsHemoglobin week 63 participants
MaintenanceAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 120 participants
MaintenanceAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 180 participants
MaintenanceAbnormal Serum LevelsNeutrophils/Leukocytes week 180 participants
MaintenanceAbnormal Serum LevelsNeutrophils/Leukocytes week 240 participants
MaintenanceAbnormal Serum LevelsPotassium week 60 participants
MaintenanceAbnormal Serum LevelsPotassium week 120 participants
MaintenanceAbnormal Serum LevelsPotassium week 180 participants
MaintenanceAbnormal Serum LevelsUrate week 120 participants
MaintenanceAbnormal Serum LevelsUrate week 180 participants
MaintenanceAbnormal Serum LevelsUrate week 240 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 03 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 03 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 182 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 243 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 122 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 182 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 242 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Volume week 02 participants
MaintenanceAbnormal Serum LevelsEry. Mean Corpuscular Volume week 62 participants
MaintenanceAbnormal Serum LevelsErythrocytes week 00 participants
MaintenanceAbnormal Serum LevelsErythrocytes week 121 participants
MaintenanceAbnormal Serum LevelsErythrocytes week 181 participants
MaintenanceAbnormal Serum LevelsErythrocytes week 240 participants
MaintenanceAbnormal Serum LevelsHematocrit week 02 participants
MaintenanceAbnormal Serum LevelsHematocrit week 63 participants
MaintenanceAbnormal Serum LevelsHematocrit week 183 participants
MaintenanceAbnormal Serum LevelsHematocrit week 241 participants
MaintenanceAbnormal Serum LevelsHemoglobin week 123 participants
MaintenanceAbnormal Serum LevelsHemoglobin week 183 participants
MaintenanceAbnormal Serum LevelsHemoglobin week 242 participants
MaintenanceAbnormal Serum LevelsLymphocytes/Leukocytes week 00 participants
MaintenanceAbnormal Serum LevelsLymphocytes/Leukocytes week 60 participants
MaintenanceAbnormal Serum LevelsLymphocytes/Leukocytes week 120 participants
MaintenanceAbnormal Serum LevelsLymphocytes/Leukocytes week 180 participants
MaintenanceAbnormal Serum LevelsLymphocytes/Leukocytes week 240 participants
MaintenanceAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 00 participants
MaintenanceAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 60 participants
MaintenanceAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 240 participants
MaintenanceAbnormal Serum LevelsNeutrophils/Leukocytes week 00 participants
MaintenanceAbnormal Serum LevelsNeutrophils/Leukocytes week 60 participants
MaintenanceAbnormal Serum LevelsNeutrophils/Leukocytes week 120 participants
MaintenanceAbnormal Serum LevelsPlatelets week 00 participants
MaintenanceAbnormal Serum LevelsPlatelets week 60 participants
MaintenanceAbnormal Serum LevelsPlatelets week 120 participants
MaintenanceAbnormal Serum LevelsPlatelets week 180 participants
MaintenanceAbnormal Serum LevelsPlatelets week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsErythrocytes week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsHematocrit week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Volume week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils/Leukocytes week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsErythrocytes week 121 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Volume week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Volume week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsBicarbonate week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsErythrocytes week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsBicarbonate week 01 participants
Pla/Ros >ULNAbnormal Serum LevelsErythrocytes week 242 participants
Pla/Ros >ULNAbnormal Serum LevelsUrate week 61 participants
Pla/Ros >ULNAbnormal Serum LevelsUrate week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsPlatelets week 241 participants
Pla/Ros >ULNAbnormal Serum LevelsHematocrit week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsTotal Bilirubin week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsTotal Bilirubin week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils/Leukocytes week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsHematocrit week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsTotal Bilirubin week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsTotal Bilirubin week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsTotal Bilirubin week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsAlbumin week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsHematocrit week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsSodium week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsSodium week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsAlbumin week 181 participants
Pla/Ros >ULNAbnormal Serum LevelsHemoglobin week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsSodium week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsSodium week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsProtein week 241 participants
Pla/Ros >ULNAbnormal Serum LevelsProtein week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsAlbumin week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsHemoglobin week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsProtein week 121 participants
Pla/Ros >ULNAbnormal Serum LevelsProtein week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsPlatelets week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsHemoglobin week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsPotassium week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsGlucose week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsPlatelets week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsHemoglobin week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsGlucose week 181 participants
Pla/Ros >ULNAbnormal Serum LevelsGlucose week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsAlbumin week 01 participants
Pla/Ros >ULNAbnormal Serum LevelsLymphocytes/Leukocytes week 01 participants
Pla/Ros >ULNAbnormal Serum LevelsGlucose week 61 participants
Pla/Ros >ULNAbnormal Serum LevelsGlucose week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsAlanine Aminotransferase week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsLymphocytes/Leukocytes week 61 participants
Pla/Ros >ULNAbnormal Serum LevelsCreatine Kinase week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsCreatine Kinase week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsChloride week 181 participants
Pla/Ros >ULNAbnormal Serum LevelsLymphocytes/Leukocytes week 121 participants
Pla/Ros >ULNAbnormal Serum LevelsCreatine Kinase week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsProtein week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsPlatelets week 61 participants
Pla/Ros >ULNAbnormal Serum LevelsLymphocytes/Leukocytes week 181 participants
Pla/Ros >ULNAbnormal Serum LevelsPotassium week 01 participants
Pla/Ros >ULNAbnormal Serum LevelsCreatine Kinase week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsAlanine Aminotransferase week 181 participants
Pla/Ros >ULNAbnormal Serum LevelsLymphocytes/Leukocytes week 241 participants
Pla/Ros >ULNAbnormal Serum LevelsCreatine Kinase week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsChloride week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsAlanine Aminotransferase week 121 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsChloride week 01 participants
Pla/Ros >ULNAbnormal Serum LevelsBlood Urea Nitrogen week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsChloride week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsBlood Urea Nitrogen week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsBlood Urea Nitrogen week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsBlood Urea Nitrogen week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsBlood Urea Nitrogen week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsPlatelets week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsUrate week 241 participants
Pla/Ros >ULNAbnormal Serum LevelsBicarbonate week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsUrate week 181 participants
Pla/Ros >ULNAbnormal Serum LevelsUrate week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsBicarbonate week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular HGB Concentration week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsSodium week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsAlanine Aminotransferase week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Hemoglobin week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsPotassium week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsPotassium week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils/Leukocytes week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Volume week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsPotassium week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsAlbumin week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsBicarbonate week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsEry. Mean Corpuscular Volume week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils/Leukocytes week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils/Leukocytes week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 180 participants
Pla/Ros >ULNAbnormal Serum LevelsNeutrophils, Segmented/Leukocytes week 120 participants
Pla/Ros >ULNAbnormal Serum LevelsAlanine Aminotransferase week 00 participants
Pla/Ros >ULNAbnormal Serum LevelsErythrocytes week 01 participants
Pla/Ros >ULNAbnormal Serum LevelsHemoglobin week 60 participants
Pla/Ros >ULNAbnormal Serum LevelsHematocrit week 240 participants
Pla/Ros >ULNAbnormal Serum LevelsChloride week 61 participants
Secondary

Abnormal Vital Signs

Safety and tolerability will be described in terms of abnormal vital signs

Time frame: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)

ArmMeasureValue (NUMBER)
C-FAS RosuvastatinAbnormal Vital Signs0 participants
Secondary

Adverse Events

Safety and tolerability will be described in terms of frequency and severity of adverse events

Time frame: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)

ArmMeasureGroupValue (NUMBER)
C-FAS RosuvastatinAdverse EventsAny AE leading to death0 adverse events
C-FAS RosuvastatinAdverse EventsAny TEAE4 adverse events
C-FAS RosuvastatinAdverse EventsAny AE4 adverse events
C-FAS RosuvastatinAdverse EventsAny SAE0 adverse events
C-FAS PlaceboAdverse EventsAny TEAE5 adverse events
C-FAS PlaceboAdverse EventsAny AE5 adverse events
C-FAS PlaceboAdverse EventsAny SAE0 adverse events
C-FAS PlaceboAdverse EventsAny AE leading to death0 adverse events
MaintenanceAdverse EventsAny AE1 adverse events
MaintenanceAdverse EventsAny SAE0 adverse events
MaintenanceAdverse EventsAny AE leading to death0 adverse events
MaintenanceAdverse EventsAny TEAE1 adverse events
Secondary

AE's Leading to Discontinuation

Safety and tolerability will be described in terms of rate of discontinuations due to adverse events

Time frame: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)

ArmMeasureValue (NUMBER)
C-FAS RosuvastatinAE's Leading to Discontinuation0 adverse events
C-FAS PlaceboAE's Leading to Discontinuation0 adverse events
MaintenanceAE's Leading to Discontinuation0 adverse events
Secondary

ApoB/ApoA

Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinApoB/ApoA2.408 ratioStandard Deviation 1.3259
C-FAS PlaceboApoB/ApoA2.873 ratioStandard Deviation 1.4669
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.01395% CI: [-32.8, -5.6]Mixed Models Analysis
Secondary

ApoB (g/L)

Efficacy in terms of apolipoprotein B (ApoB)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinApoB (g/L)2.35 g/LStandard Deviation 1.07
C-FAS PlaceboApoB (g/L)2.68 g/LStandard Deviation 0.863
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.02495% CI: [-29.2, -2.9]Mixed Models Analysis
Secondary

ApoB (mg/dL)

Efficacy in terms of apolipoprotein B (ApoB)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinApoB (mg/dL)234.9 mg/dLStandard Deviation 107.02
C-FAS PlaceboApoB (mg/dL)267.9 mg/dLStandard Deviation 86.33
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.02495% CI: [-29.2, -2.9]Mixed Models Analysis
Secondary

ECG Abnormalities

Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)

Time frame: Week 0

ArmMeasureValue (NUMBER)
C-FAS RosuvastatinECG Abnormalities0 participants
C-FAS PlaceboECG Abnormalities0 participants
MaintenanceECG Abnormalities0 participants
Secondary

HDL-C (mg/dL)

Efficacy in terms of high density lipoprotein cholesterol (HDL C)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinHDL-C (mg/dL)35.5 mg/dLStandard Deviation 7.29
C-FAS PlaceboHDL-C (mg/dL)33.7 mg/dLStandard Deviation 8.47
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.31495% CI: [-7.4, 24.5]Mixed Models Analysis
Secondary

HDL-C (mmol/L)

Efficacy in terms of high density lipoprotein cholesterol (HDL C)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinHDL-C (mmol/L)0.92 mmol/LStandard Deviation 0.189
C-FAS PlaceboHDL-C (mmol/L)0.87 mmol/LStandard Deviation 0.218
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.31495% CI: [-7.4, 24.5]Mixed Models Analysis
Secondary

Height

Safety and tolerability will be described in terms of growth, including height (linear growth \[cm and standard deviation (SD) score\]), and weight.

Time frame: Week 0 (start of cross-over), weeks 6, week 12 and week 18

ArmMeasureGroupValue (MEAN)Dispersion
C-FAS RosuvastatinHeightHeight (cm) week 6144.9 cmStandard Deviation 17.7
C-FAS RosuvastatinHeightHeight (cm) week 18146.9 cmStandard Deviation 17.68
C-FAS RosuvastatinHeightHeight (cm) week 12145.7 cmStandard Deviation 18.07
C-FAS RosuvastatinHeightHeight (cm) week 24147.1 cmStandard Deviation 17.94
C-FAS RosuvastatinHeightHeight (cm) week 0144.0 cmStandard Deviation 17.82
C-FAS PlaceboHeightHeight (cm) week 24143.5 cmStandard Deviation 17.58
C-FAS PlaceboHeightHeight (cm) week 0140.9 cmStandard Deviation 15.7
C-FAS PlaceboHeightHeight (cm) week 6141.1 cmStandard Deviation 16.11
C-FAS PlaceboHeightHeight (cm) week 12142.0 cmStandard Deviation 17.17
C-FAS PlaceboHeightHeight (cm) week 18142.3 cmStandard Deviation 16.99
Secondary

Height Z-score

Safety and tolerability will be described in terms of growth, including height (linear growth \[cm and standard deviation (SD) score\]), and weight.

Time frame: Week 0 (start of cross-over), weeks 6, week 12 and week 18

ArmMeasureGroupValue (MEAN)Dispersion
C-FAS RosuvastatinHeight Z-scoreHeight z-score week 6-0.29 ratioStandard Deviation 1.703
C-FAS RosuvastatinHeight Z-scoreHeight z-score week 180.00 ratioStandard Deviation 1.721
C-FAS RosuvastatinHeight Z-scoreHeight z-score week 12-0.18 ratioStandard Deviation 1.742
C-FAS RosuvastatinHeight Z-scoreHeight z-score week 240.04 ratioStandard Deviation 1.752
C-FAS RosuvastatinHeight Z-scoreHeight z-score week 0-0.42 ratioStandard Deviation 1.697
C-FAS PlaceboHeight Z-scoreHeight z-score week 24-0.49 ratioStandard Deviation 1.758
C-FAS PlaceboHeight Z-scoreHeight z-score week 0-0.75 ratioStandard Deviation 1.555
C-FAS PlaceboHeight Z-scoreHeight z-score week 6-0.71 ratioStandard Deviation 1.644
C-FAS PlaceboHeight Z-scoreHeight z-score week 12-0.70 ratioStandard Deviation 1.776
C-FAS PlaceboHeight Z-scoreHeight z-score week 18-0.65 ratioStandard Deviation 1.757
Secondary

LDL-C From End of Placebo (mg/dL)

Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg

Time frame: Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)

ArmMeasureGroupValue (MEAN)Dispersion
C-FAS RosuvastatinLDL-C From End of Placebo (mg/dL)End of Placebo472.9 mg/dLStandard Deviation 171.77
C-FAS RosuvastatinLDL-C From End of Placebo (mg/dL)12 weeks after end of Placebo345.8 mg/dLStandard Deviation 214.69
C-FAS RosuvastatinLDL-C From End of Placebo (mg/dL)6 weeks after end of Placebo399.4 mg/dLStandard Deviation 214.28
C-FAS RosuvastatinLDL-C From End of Placebo (mg/dL)18 weeks after end of PlaceboNA mg/dL—
C-FAS PlaceboLDL-C From End of Placebo (mg/dL)6 weeks after end of Placebo421.7 mg/dLStandard Deviation 224.49
C-FAS PlaceboLDL-C From End of Placebo (mg/dL)End of Placebo491.3 mg/dLStandard Deviation 215.46
C-FAS PlaceboLDL-C From End of Placebo (mg/dL)18 weeks after end of Placebo441.8 mg/dLStandard Deviation 260.31
C-FAS PlaceboLDL-C From End of Placebo (mg/dL)12 weeks after end of Placebo394.7 mg/dLStandard Deviation 178.45
Secondary

LDL-C From End of Placebo (mmol/L)

Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg

Time frame: Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)

ArmMeasureGroupValue (MEAN)Dispersion
C-FAS RosuvastatinLDL-C From End of Placebo (mmol/L)End of Placebo12.25 mmol/LStandard Deviation 4.449
C-FAS RosuvastatinLDL-C From End of Placebo (mmol/L)6 weeks after end of Placebo10.34 mmol/LStandard Deviation 5.551
C-FAS RosuvastatinLDL-C From End of Placebo (mmol/L)12 weeks after end of Placebo8.96 mmol/LStandard Deviation 5.558
C-FAS RosuvastatinLDL-C From End of Placebo (mmol/L)18 weeks after end of PlaceboNA mmol/L—
C-FAS PlaceboLDL-C From End of Placebo (mmol/L)18 weeks after end of Placebo11.44 mmol/LStandard Deviation 6.74
C-FAS PlaceboLDL-C From End of Placebo (mmol/L)End of Placebo12.73 mmol/LStandard Deviation 5.583
C-FAS PlaceboLDL-C From End of Placebo (mmol/L)12 weeks after end of Placebo10.22 mmol/LStandard Deviation 4.621
C-FAS PlaceboLDL-C From End of Placebo (mmol/L)6 weeks after end of Placebo10.92 mmol/LStandard Deviation 5.813
Secondary

LDL C/HDL C

Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinLDL C/HDL C12.208 ratioStandard Deviation 7.8638
C-FAS PlaceboLDL C/HDL C15.600 ratioStandard Deviation 9.1317
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00695% CI: [-41.2, -11]Mixed Models Analysis
Secondary

LDL-C, Not on Apheresis (mg/dL)

Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

Population: Patients not treated with apheresis

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinLDL-C, Not on Apheresis (mg/dL)479.8 mg/dLStandard Deviation 239.07
C-FAS PlaceboLDL-C, Not on Apheresis (mg/dL)594.7 mg/dLStandard Deviation 203.6
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.0895% CI: [-48.7, 6]Mixed Models Analysis
Secondary

LDL-C, Not on Apheresis (mmol/L)

Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

Population: Patients not treated with apheresis

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinLDL-C, Not on Apheresis (mmol/L)12.43 mmol/LStandard Deviation 6.191
C-FAS PlaceboLDL-C, Not on Apheresis (mmol/L)15.40 mmol/LStandard Deviation 5.274
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.0895% CI: [-48.7, 6]Mixed Models Analysis
Secondary

Non-HDL C/HDL C

Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinNon-HDL C/HDL C12.704 ratioStandard Deviation 8.0414
C-FAS PlaceboNon-HDL C/HDL C16.416 ratioStandard Deviation 9.5454
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00595% CI: [-41.7, -11.4]Mixed Models Analysis
Secondary

Non-HDL C (mg/dL)

Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinNon-HDL C (mg/dL)412.1 mg/dLStandard Deviation 198.62
C-FAS PlaceboNon-HDL C (mg/dL)505.3 mg/dLStandard Deviation 186.39
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00395% CI: [-33.7, -10.3]Mixed Models Analysis
Secondary

Non-HDL C (mmol/L)

Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinNon-HDL C (mmol/L)10.67 mmol/LStandard Deviation 5.144
C-FAS PlaceboNon-HDL C (mmol/L)13.09 mmol/LStandard Deviation 4.826
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00395% CI: [-33.7, -10.3]Mixed Models Analysis
Secondary

Physical Exam Abnormalitites

Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.

Time frame: Screening, Week 0, week 6, week 12 and week 18, week 24

ArmMeasureGroupValue (NUMBER)
C-FAS RosuvastatinPhysical Exam AbnormalititesLymph Nodes week 00 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesLymph Nodes week 60 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesSkin week 65 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesSkin week 125 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesGeneral Appearance screening1 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesGeneral Appearance week 01 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesGeneral Appearance week 61 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesGeneral Appearance week 121 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesGeneral Appearance week 181 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesGeneral Appearance week 241 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesHead and Neck screening0 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesHead and Neck week 00 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesHead and Neck week 60 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesHead and Neck week 120 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesHead and Neck week 180 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesHead and Neck week 240 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesLymph Nodes screening0 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesLymph Nodes week 120 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesLymph Nodes week 180 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesLymph Nodes week 240 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesSkin screening5 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesSkin week 05 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesSkin week 185 participants
C-FAS RosuvastatinPhysical Exam AbnormalititesSkin week 245 participants
C-FAS PlaceboPhysical Exam AbnormalititesHead and Neck week 62 participants
C-FAS PlaceboPhysical Exam AbnormalititesLymph Nodes week 01 participants
C-FAS PlaceboPhysical Exam AbnormalititesSkin week 122 participants
C-FAS PlaceboPhysical Exam AbnormalititesLymph Nodes week 60 participants
C-FAS PlaceboPhysical Exam AbnormalititesHead and Neck week 122 participants
C-FAS PlaceboPhysical Exam AbnormalititesSkin week 62 participants
C-FAS PlaceboPhysical Exam AbnormalititesLymph Nodes week 240 participants
C-FAS PlaceboPhysical Exam AbnormalititesHead and Neck week 182 participants
C-FAS PlaceboPhysical Exam AbnormalititesGeneral Appearance screening2 participants
C-FAS PlaceboPhysical Exam AbnormalititesSkin week 242 participants
C-FAS PlaceboPhysical Exam AbnormalititesGeneral Appearance week 02 participants
C-FAS PlaceboPhysical Exam AbnormalititesHead and Neck week 241 participants
C-FAS PlaceboPhysical Exam AbnormalititesGeneral Appearance week 62 participants
C-FAS PlaceboPhysical Exam AbnormalititesSkin screening2 participants
C-FAS PlaceboPhysical Exam AbnormalititesGeneral Appearance week 122 participants
C-FAS PlaceboPhysical Exam AbnormalititesLymph Nodes screening0 participants
C-FAS PlaceboPhysical Exam AbnormalititesGeneral Appearance week 182 participants
C-FAS PlaceboPhysical Exam AbnormalititesSkin week 182 participants
C-FAS PlaceboPhysical Exam AbnormalititesGeneral Appearance week 242 participants
C-FAS PlaceboPhysical Exam AbnormalititesLymph Nodes week 120 participants
C-FAS PlaceboPhysical Exam AbnormalititesHead and Neck screening2 participants
C-FAS PlaceboPhysical Exam AbnormalititesSkin week 02 participants
C-FAS PlaceboPhysical Exam AbnormalititesHead and Neck week 02 participants
C-FAS PlaceboPhysical Exam AbnormalititesLymph Nodes week 180 participants
Secondary

Tanner Stage

Stages for fem (Pubic hair, Breasts): 1. (Preadol,Preadol) 2. (Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr) 3. (Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation) 4. (Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound) 5. (Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes) 1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred.

Time frame: Week 0 (start of cross-over)

ArmMeasureGroupValue (MEAN)Dispersion
C-FAS RosuvastatinTanner StageTanner stage week 242.3 stageStandard Deviation 1.38
C-FAS RosuvastatinTanner StageTanner stage week 02.0 stageStandard Deviation 1.41
C-FAS PlaceboTanner StageTanner stage week 01.7 stageStandard Deviation 1.11
C-FAS PlaceboTanner StageTanner stage week 242.0 stageStandard Deviation 0.2
Secondary

TC/HDL C

Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinTC/HDL C13.704 ratioStandard Deviation 8.0414
C-FAS PlaceboTC/HDL C17.416 ratioStandard Deviation 9.5454
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00595% CI: [-38.1, -10.5]Mixed Models Analysis
Secondary

TC (mg/dL)

Efficacy in terms of total cholesterol (TC)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinTC (mg/dL)447.6 mg/dLStandard Deviation 195.46
C-FAS PlaceboTC (mg/dL)539.0 mg/dLStandard Deviation 184.91
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00395% CI: [-29.7, -9.1]Mixed Models Analysis
Secondary

TC (mmol/L)

Efficacy in terms of total cholesterol (TC)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinTC (mmol/L)11.59 mmol/LStandard Deviation 5.063
C-FAS PlaceboTC (mmol/L)13.96 mmol/LStandard Deviation 4.79
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00395% CI: [-29.7, -9.1]Mixed Models Analysis
Secondary

TG (mg/dL)

Efficacy in terms of triglycerides (TG)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinTG (mg/dL)79.8 mg/dLStandard Deviation 24.48
C-FAS PlaceboTG (mg/dL)119.5 mg/dLStandard Deviation 52.67
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00495% CI: [-44.2, -13.3]Mixed Models Analysis
Secondary

TG (mmol/L)

Efficacy in terms of triglycerides (TG)

Time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinTG (mmol/L)0.90 mmol/LStandard Deviation 0.277
C-FAS PlaceboTG (mmol/L)1.35 mmol/LStandard Deviation 0.595
Comparison: cross-over, null hypothesis is no difference between ros and plc.p-value: 0.00495% CI: [-44.2, -13.3]Mixed Models Analysis
Secondary

Trough Concentrations

Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.

Time frame: Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)

ArmMeasureValue (MEAN)Dispersion
C-FAS RosuvastatinTrough Concentrations7.387 ng/mLStandard Deviation 8.11
C-FAS PlaceboTrough Concentrations4.482 ng/mLStandard Deviation 3.5
Secondary

Urinalysis Abnormalitites

Safety and tolerability will be described in terms of abnormal urine laboratory values

Time frame: Week 0, week 6, week 12 and week 18

ArmMeasureGroupValue (NUMBER)
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Ketones week 01 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Ketones week 180 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Protein week 61 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Ketones week 240 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Protein week 242 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Blood week 01 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Protein week 123 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Blood week 62 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Ketones week 60 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Blood week 121 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Protein week 182 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Blood week 181 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Protein week 03 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Blood week 241 participants
C-FAS RosuvastatinUrinalysis AbnormalititesUrine Ketones week 120 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Blood week 241 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Protein week 241 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Ketones week 00 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Protein week 02 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Protein week 62 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Protein week 122 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Ketones week 60 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Ketones week 120 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Ketones week 181 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Ketones week 240 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Blood week 02 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Blood week 61 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Blood week 122 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Blood week 181 participants
C-FAS PlaceboUrinalysis AbnormalititesUrine Protein week 181 participants
Secondary

Weight

Safety and tolerability will be described in terms of growth, including height (linear growth \[cm and standard deviation (SD) score\]), and weight.

Time frame: Week 0 (start of cross-over), weeks 6, week 12 and week 18

ArmMeasureGroupValue (MEAN)Dispersion
C-FAS RosuvastatinWeightWeight (kg) week 638.14 kgStandard Deviation 13.577
C-FAS RosuvastatinWeightWeight (kg) week 1839.31 kgStandard Deviation 14.588
C-FAS RosuvastatinWeightWeight (kg) week 037.39 kgStandard Deviation 12.731
C-FAS RosuvastatinWeightWeight (kg) week 1238.63 kgStandard Deviation 14.426
C-FAS RosuvastatinWeightWeight (kg) week 2439.90 kgStandard Deviation 14.55
C-FAS PlaceboWeightWeight (kg) week 1242.30 kgStandard Deviation 18.651
C-FAS PlaceboWeightWeight (kg) week 040.19 kgStandard Deviation 16.52
C-FAS PlaceboWeightWeight (kg) week 640.36 kgStandard Deviation 16.462
C-FAS PlaceboWeightWeight (kg) week 2443.00 kgStandard Deviation 17.867
C-FAS PlaceboWeightWeight (kg) week 1842.50 kgStandard Deviation 17.99

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026