Metabolic Syndrome
Conditions
Keywords
plasma lipid profile, metabolic syndrome
Brief summary
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.
Interventions
DRUGrosuvastatin
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria) * LDL-Cholesterol \> 130mg/dl * HDL-Cholesterol \< 40mg/dl in males and \<50mg/dl in females * Triglycerides \< 400 mg/dl
Exclusion criteria
* With a concomitant coronary disease * Currently under statin therapy or previously treated with statins within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Basal LDL-cholesterol Level | Baseline | LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) |
| Basal Triglyceride Level | Baseline | Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment) |
| LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Total Cholesterol Level | Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline |
| Total Cholesterol Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal HDL-cholesterol Level | Baseline | HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) |
| HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Triglyceride Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: \<100 mg/dL; HDL-cholesterol: For males \>40 mg/dL, for females \>50 mg/dL; non-HDL-cholesterol: \<130 mg/dL |
| Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment |
| Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal LDL-3 Level | Baseline | LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls |
| LDL-3 Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal LDL-4 Level | Baseline | LDL-4 levels before (Visit 2-enrollment) |
| LDL-4 Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal LDL-5 Level | Baseline | LDL-5 levels before (Visit 2-enrollment) |
| LDL-5 Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal LDL-6 Level | Baseline | LDL-6 levels before (Visit 2-enrollment) |
| LDL-6 Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Interleukin 6 (IL-6) Level | Baseline | IL-6 levels before (Visit 2-enrollment) |
| LDL-7 Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Large HDL Subfraction Level | Baseline | Large HDL subfraction levels before (Visit 2-enrollment) |
| Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Intermediate HDL Subfraction Level | Baseline | Intermediate HDL subfraction levels before (Visit 2-enrollment) |
| Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Small HDL Subfraction Level | Baseline | Small HDL subfraction levels before (Visit 2-enrollment) |
| Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Number of Patients With Adverse Events | 3 months (from enrollment to last visit) | Number of patients with any adverse events in 3 months of rosuvastatin treatment |
| Basal LDL-7 Level | Baseline | LDL-7 levels before (Visit 2-enrollment) |
| Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Interleukin 1 (IL-1) Level | Baseline | IL-1 levels before (Visit 2-enrollment) |
| Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Interleukin 8 (IL-8) Level | Baseline | IL-8 levels before (Visit 2-enrollment) |
| Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Interleukin 10 (IL-10) Level | Baseline | IL-10 levels before (Visit 2-enrollment) |
| Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal Tumor Necrosis Factor (TNF) Level | Baseline | TNF levels before (Visit 2-enrollment) |
| Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment | 3 months (from enrollment to last visit) | TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) |
| Basal High Sensitivity C-reactive Protein (Hs-CRP) Level | Baseline | hs-CRP levels before (Visit 2-enrollment) |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crestor Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks | 97 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Crestor |
|---|---|
| Age Continuous | 50.9 Years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 97 |
| serious Total, serious adverse events | 0 / 97 |
Outcome results
Primary
Basal HDL-cholesterol Level
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal HDL-cholesterol Level | 39.5 mg/dL | Standard Deviation 6.5 |
Primary
Basal LDL-cholesterol Level
LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time frame: Baseline
Population: Baseline LDL levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal LDL-cholesterol Level | 165.5 mg/dL | Standard Deviation 32 |
Primary
Basal Total Cholesterol Level
Baseline
Time frame: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Population: Baseline total cholesterol levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Total Cholesterol Level | 236.5 mg/dL | Standard Deviation 38.2 |
Primary
Basal Triglyceride Level
Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Time frame: Baseline
Population: Baseline triglyceride levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Triglyceride Level | 195.1 mg/dL | Standard Deviation 65.3 |
Primary
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) HDL levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | 43.4 mg/dL | Standard Deviation 9.8 |
Primary
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) LDL levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | 98.3 mg/dL | Standard Deviation 44.8 |
Primary
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment
Time frame: 3 months (from enrollment to last visit)
Population: HDL cholesterol target levels for males \>40 mg/dL, for females \> 50 mg/dL, calculated over patients with lipid measurement performed at both visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crestor | Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment | 39 Participants |
Primary
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: \<100 mg/dL; HDL-cholesterol: For males \>40 mg/dL, for females \>50 mg/dL; non-HDL-cholesterol: \<130 mg/dL
Time frame: 3 months (from enrollment to last visit)
Population: LDL cholesterol levels \< 100 mg/dL, calculated over patients with lipid measurement performed at both visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crestor | Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment | 48 Participants |
Primary
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment
Time frame: 3 months (from enrollment to last visit)
Population: Non-HDL cholesterol target levels \<130 mg/dL, calculated over patients with lipid measurement performed at both visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crestor | Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment | 51 Participants |
Primary
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) total cholesterol levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Total Cholesterol Level After 3 Months of Rosuvastatin Treatment | 166.2 mg/dL | Standard Deviation 47.7 |
Primary
Triglyceride Level After 3 Months of Rosuvastatin Treatment
Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) triglyceride levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Triglyceride Level After 3 Months of Rosuvastatin Treatment | 153.1 mg/dL | Standard Deviation 76.8 |
Secondary
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level
hs-CRP levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal High Sensitivity C-reactive Protein (Hs-CRP) Level | 8.2 mg/mL | Standard Deviation 7.3 |
Secondary
Basal Interleukin 10 (IL-10) Level
IL-10 levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline IL-10 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Interleukin 10 (IL-10) Level | 4.2 pg/mL | Standard Deviation 2.1 |
Secondary
Basal Interleukin 1 (IL-1) Level
IL-1 levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline IL-1 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Interleukin 1 (IL-1) Level | 4.1 pg/mL | Standard Deviation 2.3 |
Secondary
Basal Interleukin 6 (IL-6) Level
IL-6 levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline IL-6 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Interleukin 6 (IL-6) Level | 2.6 pg/mL | Standard Deviation 2.1 |
Secondary
Basal Interleukin 8 (IL-8) Level
IL-8 levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline IL-8 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Interleukin 8 (IL-8) Level | 10.7 pg/mL | Standard Deviation 5.1 |
Secondary
Basal Intermediate HDL Subfraction Level
Intermediate HDL subfraction levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline Intermediate HDL subfraction of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Intermediate HDL Subfraction Level | 18.9 mg/mL | Standard Deviation 5.7 |
Secondary
Basal Large HDL Subfraction Level
Large HDL subfraction levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline Large HDL subfraction of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Large HDL Subfraction Level | 15.0 mg/mL | Standard Deviation 6.4 |
Secondary
Basal LDL-3 Level
LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls
Time frame: Baseline
Population: Baseline LDL-3 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal LDL-3 Level | 15.5 mg/mL | Standard Deviation 9.5 |
Secondary
Basal LDL-4 Level
LDL-4 levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline LDL-4 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal LDL-4 Level | 7.9 mg/mL | Standard Deviation 9.6 |
Secondary
Basal LDL-5 Level
LDL-5 levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline LDL-5 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal LDL-5 Level | 2.7 mg/mL | Standard Deviation 7.1 |
Secondary
Basal LDL-6 Level
LDL-6 levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline LDL-6 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal LDL-6 Level | 0.5 mg/mL | Standard Deviation 2.6 |
Secondary
Basal LDL-7 Level
LDL-7 levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline LDL-7 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal LDL-7 Level | 0.5 mg/mL | Standard Deviation 3 |
Secondary
Basal Small HDL Subfraction Level
Small HDL subfraction levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline Small HDL subfraction of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Small HDL Subfraction Level | 6.2 mg/mL | Standard Deviation 4.2 |
Secondary
Basal Tumor Necrosis Factor (TNF) Level
TNF levels before (Visit 2-enrollment)
Time frame: Baseline
Population: Baseline Basal Tumor Necrosis Factor (TNF) levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Basal Tumor Necrosis Factor (TNF) Level | 10.8 pg/mL | Standard Deviation 5.3 |
Secondary
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment
hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment | 6.7 mg/mL | Standard Deviation 5.6 |
Secondary
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment
IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) IL-10 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment | 4.8 pg/mL | Standard Deviation 3.9 |
Secondary
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment
IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) IL-1 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment | 4.1 pg/mL | Standard Deviation 2.2 |
Secondary
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment
IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) IL-6 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment | 2.8 pg/mL | Standard Deviation 2.8 |
Secondary
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment
IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) IL-8 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment | 12.7 pg/mL | Standard Deviation 13.3 |
Secondary
Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) Intermediate HDL subfraction levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | 19.9 mg/mL | Standard Deviation 6.1 |
Secondary
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) Large HDL subfraction levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | 17.6 mg/mL | Standard Deviation 7.6 |
Secondary
LDL-3 Level After 3 Months of Rosuvastatin Treatment
LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) LDL-3 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | LDL-3 Level After 3 Months of Rosuvastatin Treatment | 8.8 mg/mL | Standard Deviation 7.9 |
Secondary
LDL-4 Level After 3 Months of Rosuvastatin Treatment
LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF(Last Observation Carried Forward) LDL-4 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | LDL-4 Level After 3 Months of Rosuvastatin Treatment | 3.5 mg/mL | Standard Deviation 4.8 |
Secondary
LDL-5 Level After 3 Months of Rosuvastatin Treatment
LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) LDL-5 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | LDL-5 Level After 3 Months of Rosuvastatin Treatment | 1.3 mg/mL | Standard Deviation 3.5 |
Secondary
LDL-6 Level After 3 Months of Rosuvastatin Treatment
LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) LDL-6 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | LDL-6 Level After 3 Months of Rosuvastatin Treatment | 0.3 mg/mL | Standard Deviation 1.5 |
Secondary
LDL-7 Level After 3 Months of Rosuvastatin Treatment
LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) LDL-7 levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | LDL-7 Level After 3 Months of Rosuvastatin Treatment | 0.8 mg/mL | Standard Deviation 5.3 |
Secondary
Number of Patients With Adverse Events
Number of patients with any adverse events in 3 months of rosuvastatin treatment
Time frame: 3 months (from enrollment to last visit)
Population: Number of patients with any adverse events in 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crestor | Number of Patients With Adverse Events | 24 Participants |
Secondary
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) Small HDL subfraction levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | 6.6 mg/mL | Standard Deviation 4.6 |
Secondary
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment
TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Time frame: 3 months (from enrollment to last visit)
Population: LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crestor | Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment | 12.9 pg/mL | Standard Deviation 9.2 |