| Primary | Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins. | Modified Intent To Treat (MITT) Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-40.2(-45.3 to -32.5)
- OG001-33.7(-39.6 to -28.3)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANOVA | | 0.0002 | | | | | | | 95 | | | | | | Yes | Non-Inferiority or Equivalence | Non-inferiority of the non-HDL-C response was assessed by calculating the 2-sided 90% and 95% confidence intervals (CIs)for each difference in response based on comparing the effects of increases in atorvastatin dose on the percent changes from baseline to the end of each atorvastatin period, a repeated-ANOVA model was used. | |
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| Secondary | Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Total Cholesterol is the sum of the High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), Very Low Density Lipoproteins (VLDL), and Intermediate Density Lipoproteins (IDL). | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | HDL - A complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease. High density lipoprotein cholesterol is the Total Cholesterol minus the sum of the LDL, VLDL and IDL. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
|
| Secondary | Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | LDL - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Triglycerides - A naturally occurring ester of three fatty acids and glycerol that is the chief constituent of fats and oils. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | VLDL - very-low-density lipoprotein: a plasma lipoprotein with a high lipid content, associated with atherosclerosis. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Apolipoprotein A1 - major protein component of high density lipoprotein (HDL) in plasma. The protein promotes cholesterol efflux from tissues to the liver for excretion. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Post-Hoc | Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Apolipoprotein B is the primary apolipoprotein of low density lipoproteins (LDL or "bad cholesterol"), which is responsible for carrying cholesterol to tissues. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Apolipoprotein C-III (APOC3) is a very low density lipoprotein (VLDL) protein. APOC3 inhibits lipoprotein lipase and hepatic lipase; it is thought to delay catabolism of triglyceride-rich particles. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Total cholesterol/High density lipoprotein cholesterol | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Docosahexaenoic Acid is an omega-3 essential fatty acid. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Eicosapentaenoic acid (EPA) is one of several omega-3 fatty acids used by the body. It is found in cold water fatty fish and in fish oil supplements, along with docosahexaenoic acid (DHA). Omega-3 fatty acids are part of a healthy diet that helps lower risk of heart disease. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
|
| Secondary | Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease. Researchers have linked LDL particle size to the subsequent development of heart disease. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Lipoprotein Phosphoslipase A2 - modified form of LDL. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | High Density Lipoprotein partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
|
| Secondary | Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis. Chylomicrons are One of the microscopic particles of emulsified fat found in the blood and lymph and formed during the digestion of fats. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
|
| Secondary | Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Intermediate Density Lipoprotein, or IDLs, transport cholesterol and triglycerides through the body. IDLs are a type of cholesterol that are a product of VLDL degradation and result in LDL cholesterol when broken down. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Remnant-like particle cholesterol within the plasma has been identified as a cardiovascular risk factor. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period | Adiponectin is a protein hormone that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
| |
| Secondary | Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period | Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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| Secondary | Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period | Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins. | Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | Lovaza(Omacor) + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks. | | OG001 | Placebo + Atorvastatin | Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks. |
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