Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia (NCT NCT00435045)
NCT ID: NCT00435045
Last Updated: 2017-02-02
Results Overview
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.
COMPLETED
PHASE3
245 participants
Baseline and Week 8
2017-02-02
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Weeks 1-8 / 10 mg Dose Level
STARTED
|
123
|
122
|
|
Weeks 1-8 / 10 mg Dose Level
COMPLETED
|
118
|
118
|
|
Weeks 1-8 / 10 mg Dose Level
NOT COMPLETED
|
5
|
4
|
|
Weeks 9-12 / 20mg Dose Level
STARTED
|
118
|
118
|
|
Weeks 9-12 / 20mg Dose Level
COMPLETED
|
113
|
113
|
|
Weeks 9-12 / 20mg Dose Level
NOT COMPLETED
|
5
|
5
|
|
Weeks 13-16 / 40mg Dose Level
STARTED
|
113
|
113
|
|
Weeks 13-16 / 40mg Dose Level
COMPLETED
|
108
|
111
|
|
Weeks 13-16 / 40mg Dose Level
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Weeks 1-8 / 10 mg Dose Level
Adverse Event
|
1
|
1
|
|
Weeks 1-8 / 10 mg Dose Level
Lost to Follow-up
|
1
|
1
|
|
Weeks 1-8 / 10 mg Dose Level
Withdrawal by Subject
|
2
|
1
|
|
Weeks 1-8 / 10 mg Dose Level
Family Crisis - could not participate
|
1
|
0
|
|
Weeks 1-8 / 10 mg Dose Level
Requirement for Excluded Medications
|
0
|
1
|
|
Weeks 9-12 / 20mg Dose Level
Adverse Event
|
4
|
3
|
|
Weeks 9-12 / 20mg Dose Level
Lost to Follow-up
|
1
|
1
|
|
Weeks 9-12 / 20mg Dose Level
Withdrawal by Subject
|
0
|
1
|
|
Weeks 13-16 / 40mg Dose Level
Adverse Event
|
3
|
2
|
|
Weeks 13-16 / 40mg Dose Level
Withdrawal by Subject
|
1
|
0
|
|
Weeks 13-16 / 40mg Dose Level
Per Sponsors Request
|
1
|
0
|
Baseline Characteristics
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Baseline characteristics by cohort
| Measure |
Lovaza(Omacor) + Atorvastatin
n=123 Participants
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.
|
Placebo + Atorvastatin
n=122 Participants
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.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
|
Gender
Female
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Gender
Male
|
71 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
108 participants
n=5 Participants
|
110 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=121 Participants
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.
|
|---|---|---|
|
Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-40.2 percent change
Interval -45.3 to -32.5
|
-33.7 percent change
Interval -39.6 to -28.3
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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).
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=121 Participants
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.
|
|---|---|---|
|
Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-31.5 percent change
Interval -36.0 to -25.3
|
-27.4 percent change
Interval -31.7 to -22.2
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=121 Participants
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.
|
|---|---|---|
|
Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
12.4 percent change
Interval 3.6 to 22.9
|
10.0 percent change
Interval -1.2 to 16.3
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=120 Participants
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.
|
|---|---|---|
|
Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-29.3 percent change
Interval -41.1 to -18.4
|
-31.5 percent change
Interval -41.4 to -23.4
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Triglycerides - A naturally occurring ester of three fatty acids and glycerol that is the chief constituent of fats and oils.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=121 Participants
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.
|
|---|---|---|
|
Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-45.4 percent change
Interval -55.3 to -34.9
|
-26.9 percent change
Interval -38.7 to -14.4
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
VLDL - very-low-density lipoprotein: a plasma lipoprotein with a high lipid content, associated with atherosclerosis.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=120 Participants
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.
|
|---|---|---|
|
Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-54.3 percent change
Interval -66.7 to -36.7
|
-37.0 percent change
Interval -50.9 to -17.8
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Apolipoprotein A1 - major protein component of high density lipoprotein (HDL) in plasma. The protein promotes cholesterol efflux from tissues to the liver for excretion.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=121 Participants
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.
|
|---|---|---|
|
Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-0.3 percent change
Interval -7.0 to 9.0
|
1.5 percent change
Interval -4.5 to 10.4
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=119 Participants
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.
|
|---|---|---|
|
Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-29.4 percent change
Interval -36.8 to -17.4
|
-16.0 percent change
Interval -27.3 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Total cholesterol/High density lipoprotein cholesterol
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=121 Participants
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.
|
|---|---|---|
|
Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-38.3 percent change
Interval -44.9 to -31.9
|
-34.5 percent change
Interval -40.3 to -25.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=121 Participants
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.
|
|---|---|---|
|
Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-51.9 percent change
Interval -62.4 to -39.8
|
-34.0 percent change
Interval -47.3 to -14.9
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Docosahexaenoic Acid is an omega-3 essential fatty acid.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=101 Participants
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.
|
Placebo + Atorvastatin
n=103 Participants
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.
|
|---|---|---|
|
Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
85.5 percent change
Interval 49.4 to 125.6
|
4.2 percent change
Interval -5.7 to 13.4
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=101 Participants
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.
|
Placebo + Atorvastatin
n=103 Participants
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.
|
|---|---|---|
|
Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
402.2 percent change
Interval 276.8 to 570.8
|
-5.6 percent change
Interval -20.0 to 14.9
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-34.6 percent change
Interval -42.9 to -24.0
|
-32.2 percent change
Interval -41.2 to -23.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
1.5 percent change
Interval -0.5 to 4.1
|
0.5 percent change
Interval -1.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Lipoprotein Phosphoslipase A2 - modified form of LDL.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-20.7 percent change
Interval -27.5 to -10.0
|
-9.7 percent change
Interval -17.6 to -0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
1.0 percent change
Interval -8.9 to 8.4
|
5.1 percent change
Interval -1.3 to 11.9
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
0.0 percent change
Interval -1.2 to 2.4
|
1.2 percent change
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-32.4 percent change
Interval -50.5 to -14.6
|
-25.9 percent change
Interval -39.0 to -4.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-17.5 percent change
Interval -26.0 to -9.5
|
-3.3 percent change
Interval -11.5 to 10.1
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=114 Participants
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.
|
Placebo + Atorvastatin
n=112 Participants
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.
|
|---|---|---|
|
Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-60.4 percent change
Interval -87.9 to -18.6
|
-50.3 percent change
Interval -77.2 to -20.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Remnant-like particle cholesterol within the plasma has been identified as a cardiovascular risk factor.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=118 Participants
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.
|
Placebo + Atorvastatin
n=119 Participants
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.
|
|---|---|---|
|
Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-50.0 percent change
Interval -61.1 to -38.5
|
-38.9 percent change
Interval -53.1 to -18.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Adiponectin is a protein hormone that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=119 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-5.1 percent change
Interval -15.2 to 8.2
|
-1.6 percent change
Interval -12.6 to 7.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=117 Participants
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.
|
Placebo + Atorvastatin
n=118 Participants
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.
|
|---|---|---|
|
Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period
|
-46.9 percent change
Interval -52.2 to -40.1
|
-39.0 percent change
Interval -45.3 to -33.5
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: 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.
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.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=113 Participants
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.
|
Placebo + Atorvastatin
n=112 Participants
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.
|
|---|---|---|
|
Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period
|
-50.4 percent change
Interval -57.6 to -43.3
|
-46.3 percent change
Interval -51.7 to -40.3
|
POST_HOC outcome
Timeframe: Baseline and Week 8Population: 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.
Apolipoprotein B is the primary apolipoprotein of low density lipoproteins (LDL or "bad cholesterol"), which is responsible for carrying cholesterol to tissues.
Outcome measures
| Measure |
Lovaza(Omacor) + Atorvastatin
n=122 Participants
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.
|
Placebo + Atorvastatin
n=121 Participants
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.
|
|---|---|---|
|
Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
|
-32.1 percent change
Interval -40.1 to -24.2
|
-30.7 percent change
Interval -36.0 to -23.0
|
Adverse Events
Lovaza(Omacor) + Atorvastatin
Placebo + Atorvastatin
Serious adverse events
| Measure |
Lovaza(Omacor) + Atorvastatin
n=123 participants at risk
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.
|
Placebo + Atorvastatin
n=122 participants at risk
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.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/122
|
0.82%
1/122
|
|
Nervous system disorders
Syncope
|
0.00%
0/122
|
0.82%
1/122
|
|
Vascular disorders
Peripheral Ischemia
|
0.82%
1/122
|
0.00%
0/122
|
|
Infections and infestations
Lobar Pneumonia
|
0.82%
1/122
|
0.00%
0/122
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain/ Dyspnea
|
0.82%
1/122
|
0.00%
0/122
|
|
Infections and infestations
Labyrinthitis
|
0.82%
1/122
|
0.00%
0/122
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER