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| ID | Type | Description | Link |
|---|---|---|---|
| ROMEO |
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The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental |
| |
| Atorvastatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 10mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 | Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Reaching Their LDL-C Target Goal | Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk). | Baseline and 6 weeks |
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Inclusion Criteria:
Presence of 3 or more of the following criteria;
Elevated LDL-C ;
Triglyceride < 500 mg/dL
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| Name | Affiliation | Role |
|---|---|---|
| JoonWoo Bahn, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Pusan | South Korea | ||||
| Research Site |
Enrolled patients to be randomized should complete 6-week dietary run-in periods. Also, LDL level should be ≥ 130mg/dl & < 220mg/dl and triglyceride should be < 500mg/dl.
A total of 613 subjects were enrolled in the study at 13 centres, of whom 258 were randomized to treatment with rosuvastatin (n=132) or atorvastatin (n=126). Subjects were recruited throughout South Korea from September 2006 to June 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosuvastatin | 10mg |
| FG001 | Atorvastatin | 10mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosuvastatin | 10mg |
| BG001 | Atorvastatin | 10mg |
| BG002 |
| 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 | Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 | Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1. | Posted | May 2009 | Mean | Standard Deviation | percent change | Baseline and 6 weeks |
|
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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 | Rosuvastatin | 10mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac 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 |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Atorvastatin |
| Drug |
10mg |
|
| Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal | Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal. | Baseline and 6 weeks |
| Percentage Change of Glucose Level | Using laboratory test, mean change of glucose level was investigated. | Baseline and 6 weeks |
| Percentage Change of Insulin Resistance Using HOMA-R | HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5 | Baseline and 6 weeks |
| Percentage Change of Insulin Resistance Using QUICKI | QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)]. | Baseline and 6 weeks |
| Percentage Reduction of Low-Density Lipoprotein-C (LDL-C) | Calculate the percentage reduction of LDL-C | Baseline and 6 weeks |
| Percentage Change of Total Cholesterol (TC) | Calculate the percentage change of total cholesterol level | Baseline and 6 weeks |
| Percentage Change of High-Density Lipoprotein-C (HDL-C) | Calculate the percentage change of HDL-C level | Baseline and 6 weeks |
| Percentage Change of Triglycerides (TG) | Calculate the percentage change of Triglycerides. | Baseline and 6 weeks |
| Percentage Change of Apolipoprotein A1 (ApoA1) | Calculate the percentage change of Apolipoprotein A1 | Baseline and 6 weeks |
| Percentage Change of Apolipoprotein B (ApoB) | Calculate the percentage change of apolipoprotein B | Baseline and 6 weeks |
| Seoul |
| South Korea |
| Research Site | Suwon | South Korea |
| Lost to Follow-up |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Subjects Reaching Their LDL-C Target Goal | Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk). | Posted | May 2009 | Number | percentage of participants | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal | Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal. | Posted | May 2009 | Number | percentage of participants | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Change of Glucose Level | Using laboratory test, mean change of glucose level was investigated. | Posted | May 2009 | Mean | Standard Deviation | Percentage change | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Change of Insulin Resistance Using HOMA-R | HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5 | Posted | May 2009 | Mean | Standard Deviation | percentage change | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Change of Insulin Resistance Using QUICKI | QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)]. | Posted | May 2009 | Mean | Standard Deviation | percentage change | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Reduction of Low-Density Lipoprotein-C (LDL-C) | Calculate the percentage reduction of LDL-C | Posted | May 2009 | Mean | Standard Deviation | percentage reduction | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Change of Total Cholesterol (TC) | Calculate the percentage change of total cholesterol level | Posted | May 2009 | Mean | Standard Deviation | percentage change | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Change of High-Density Lipoprotein-C (HDL-C) | Calculate the percentage change of HDL-C level | Posted | May 2009 | Mean | Standard Deviation | percentage change | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Change of Triglycerides (TG) | Calculate the percentage change of Triglycerides. | Posted | May 2009 | Mean | Standard Deviation | percentage change | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Change of Apolipoprotein A1 (ApoA1) | Calculate the percentage change of Apolipoprotein A1 | Posted | May 2009 | Mean | Standard Deviation | percentage change | Baseline and 6 weeks |
|
|
|
| Secondary | Percentage Change of Apolipoprotein B (ApoB) | Calculate the percentage change of apolipoprotein B | Posted | May 2009 | Mean | Standard Deviation | percentage change | Baseline and 6 weeks |
|
|
|
| 0 |
| 129 |
| 0 |
| 129 |
| EG001 | Atorvastatin | 10mg | 4 | 124 | 0 | 124 |
| Enteritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
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| 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 |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |