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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosuvastatin | Drug | medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Basal HDL-cholesterol Level | HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline |
| HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal LDL-cholesterol Level | LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline |
| LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal Total Cholesterol Level | Baseline | Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) |
| Total Cholesterol Level After 3 Months of Rosuvastatin Treatment | Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal Triglyceride Level | Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Basal Interleukin 1 (IL-1) Level | IL-1 levels before (Visit 2-enrollment) | Baseline |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dilek Ural, MD, Prof | Kocaeli University Faculty of Medicine Cardiology Dept | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Ankara | Besevler | Turkey (Türkiye) | |||
| Research site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Crestor | Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Crestor | Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Basal HDL-cholesterol Level | HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Posted | Mean | Standard Deviation | mg/dL | Baseline |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crestor | Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Triglyceride Level After 3 Months of Rosuvastatin Treatment | Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| 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 | 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 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 | Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment | 3 months (from enrollment to last visit) |
| 3 months (from enrollment to last visit) |
| Basal Interleukin 6 (IL-6) Level | IL-6 levels before (Visit 2-enrollment) | Baseline |
| 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) | 3 months (from enrollment to last visit) |
| Basal Interleukin 8 (IL-8) Level | IL-8 levels before (Visit 2-enrollment) | Baseline |
| 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) | 3 months (from enrollment to last visit) |
| Basal Interleukin 10 (IL-10) Level | IL-10 levels before (Visit 2-enrollment) | Baseline |
| 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) | 3 months (from enrollment to last visit) |
| Basal Tumor Necrosis Factor (TNF) Level | TNF levels before (Visit 2-enrollment) | Baseline |
| Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment | TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal High Sensitivity C-reactive Protein (Hs-CRP) Level | hs-CRP levels before (Visit 2-enrollment) | Baseline |
| 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) | 3 months (from enrollment to last visit) |
| 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 | Baseline |
| LDL-3 Level After 3 Months of Rosuvastatin Treatment | LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal LDL-4 Level | LDL-4 levels before (Visit 2-enrollment) | Baseline |
| LDL-4 Level After 3 Months of Rosuvastatin Treatment | LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal LDL-5 Level | LDL-5 levels before (Visit 2-enrollment) | Baseline |
| LDL-5 Level After 3 Months of Rosuvastatin Treatment | LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal LDL-6 Level | LDL-6 levels before (Visit 2-enrollment) | Baseline |
| LDL-6 Level After 3 Months of Rosuvastatin Treatment | LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal LDL-7 Level | LDL-7 levels before (Visit 2-enrollment) | Baseline |
| LDL-7 Level After 3 Months of Rosuvastatin Treatment | LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) |
| Basal Large HDL Subfraction Level | Large HDL subfraction levels before (Visit 2-enrollment) | Baseline |
| 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) | 3 months (from enrollment to last visit) |
| Basal Intermediate HDL Subfraction Level | Intermediate HDL subfraction levels before (Visit 2-enrollment) | Baseline |
| 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) | 3 months (from enrollment to last visit) |
| Basal Small HDL Subfraction Level | Small HDL subfraction levels before (Visit 2-enrollment) | Baseline |
| 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) | 3 months (from enrollment to last visit) |
| Number of Patients With Adverse Events | Number of patients with any adverse events in 3 months of rosuvastatin treatment | 3 months (from enrollment to last visit) |
| Kayseri |
| Erciyes |
| Turkey (Türkiye) |
| Research site | Istanbul | Haseki | Turkey (Türkiye) |
| Research site | Kocaeli | Umuttepe | Turkey (Türkiye) |
| Research Site | Izmir | Turkey (Türkiye) |
| Research Site | Trabzon | Turkey (Türkiye) |
| Protocol Violation |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF (Last Observation Carried Forward) HDL levels of participants | Posted | Mean | Standard Deviation | mg/dL | 3 months (from enrollment to last visit) |
|
|
|
| Primary | Basal LDL-cholesterol Level | LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline LDL levels of participants | Posted | Mean | Standard Deviation | mg/dL | Baseline |
|
|
|
| Primary | LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF (Last Observation Carried Forward) LDL levels of participants | Posted | Mean | Standard Deviation | mg/dL | 3 months (from enrollment to last visit) |
|
|
|
| Primary | Basal Total Cholesterol Level | Baseline | Baseline total cholesterol levels of participants | Posted | Mean | Standard Deviation | mg/dL | Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) |
|
|
|
| Primary | Total Cholesterol Level After 3 Months of Rosuvastatin Treatment | Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF (Last Observation Carried Forward) total cholesterol levels of participants | Posted | Mean | Standard Deviation | mg/dL | 3 months (from enrollment to last visit) |
|
|
|
| Primary | Basal Triglyceride Level | Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline triglyceride levels of participants | Posted | Mean | Standard Deviation | mg/dL | Baseline |
|
|
|
| Primary | Triglyceride Level After 3 Months of Rosuvastatin Treatment | Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF (Last Observation Carried Forward) triglyceride levels of participants | Posted | Mean | Standard Deviation | mg/dL | 3 months (from enrollment to last visit) |
|
|
|
| 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 | LDL cholesterol levels < 100 mg/dL, calculated over patients with lipid measurement performed at both visits | Posted | Number | Participants | 3 months (from enrollment to last visit) |
|
|
|
| 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 | HDL cholesterol target levels for males >40 mg/dL, for females > 50 mg/dL, calculated over patients with lipid measurement performed at both visits | Posted | Number | Participants | 3 months (from enrollment to last visit) |
|
|
|
| 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 | Non-HDL cholesterol target levels <130 mg/dL, calculated over patients with lipid measurement performed at both visits | Posted | Number | Participants | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal Interleukin 1 (IL-1) Level | IL-1 levels before (Visit 2-enrollment) | Baseline IL-1 levels of participants | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) IL-1 levels of participants | Posted | Mean | Standard Deviation | pg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal Interleukin 6 (IL-6) Level | IL-6 levels before (Visit 2-enrollment) | Baseline IL-6 levels of participants | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) IL-6 levels of participants | Posted | Mean | Standard Deviation | pg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal Interleukin 8 (IL-8) Level | IL-8 levels before (Visit 2-enrollment) | Baseline IL-8 levels of participants | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) IL-8 levels of participants | Posted | Mean | Standard Deviation | pg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal Interleukin 10 (IL-10) Level | IL-10 levels before (Visit 2-enrollment) | Baseline IL-10 levels of participants | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) IL-10 levels of participants | Posted | Mean | Standard Deviation | pg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal Tumor Necrosis Factor (TNF) Level | TNF levels before (Visit 2-enrollment) | Baseline Basal Tumor Necrosis Factor (TNF) levels of participants | Posted | Mean | Standard Deviation | pg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants | Posted | Mean | Standard Deviation | pg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal High Sensitivity C-reactive Protein (Hs-CRP) Level | hs-CRP levels before (Visit 2-enrollment) | Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| 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 | Baseline LDL-3 levels of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| Secondary | LDL-3 Level After 3 Months of Rosuvastatin Treatment | LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF (Last Observation Carried Forward) LDL-3 levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal LDL-4 Level | LDL-4 levels before (Visit 2-enrollment) | Baseline LDL-4 levels of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| Secondary | LDL-4 Level After 3 Months of Rosuvastatin Treatment | LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF(Last Observation Carried Forward) LDL-4 levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal LDL-5 Level | LDL-5 levels before (Visit 2-enrollment) | Baseline LDL-5 levels of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| Secondary | LDL-5 Level After 3 Months of Rosuvastatin Treatment | LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF (Last Observation Carried Forward) LDL-5 levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal LDL-6 Level | LDL-6 levels before (Visit 2-enrollment) | Baseline LDL-6 levels of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| Secondary | LDL-6 Level After 3 Months of Rosuvastatin Treatment | LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF (Last Observation Carried Forward) LDL-6 levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal LDL-7 Level | LDL-7 levels before (Visit 2-enrollment) | Baseline LDL-7 levels of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| Secondary | LDL-7 Level After 3 Months of Rosuvastatin Treatment | LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | LOCF (Last Observation Carried Forward) LDL-7 levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal Large HDL Subfraction Level | Large HDL subfraction levels before (Visit 2-enrollment) | Baseline Large HDL subfraction of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) Large HDL subfraction levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal Intermediate HDL Subfraction Level | Intermediate HDL subfraction levels before (Visit 2-enrollment) | Baseline Intermediate HDL subfraction of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) Intermediate HDL subfraction levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Basal Small HDL Subfraction Level | Small HDL subfraction levels before (Visit 2-enrollment) | Baseline Small HDL subfraction of participants | Posted | Mean | Standard Deviation | mg/mL | Baseline |
|
|
|
| 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) | LOCF (Last Observation Carried Forward) Small HDL subfraction levels of participants | Posted | Mean | Standard Deviation | mg/mL | 3 months (from enrollment to last visit) |
|
|
|
| Secondary | Number of Patients With Adverse Events | Number of patients with any adverse events in 3 months of rosuvastatin treatment | Number of patients with any adverse events in 3 months | Posted | Number | Participants | 3 months (from enrollment to last visit) |
|
|
|
| 0 |
| 97 |
| 29 |
| 97 |
| CK Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Dysuria | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus-Allergy-Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Allergy | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatoid | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eye Twitching | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Blood Pressure Increased | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Weight Increased | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leg Cramp | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leg Swelling | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough-Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Liver Function Tests Abnormal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |