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Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia

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ClinicalTrials.gov Identifier: NCT00435045
Recruitment Status : Completed
First Posted : February 14, 2007
Results First Posted : May 12, 2009
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypertriglyceridemia
Interventions Drug: Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin
Drug: atorvastatin
Enrollment 245
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description 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. 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.
Period Title: Weeks 1-8 / 10 mg Dose Level
Started 123 122
Completed 118 118
Not Completed 5 4
Reason Not Completed
Adverse Event             1             1
Lost to Follow-up             1             1
Withdrawal by Subject             2             1
Family Crisis - could not participate             1             0
Requirement for Excluded Medications             0             1
Period Title: Weeks 9-12 / 20mg Dose Level
Started 118 118
Completed 113 113
Not Completed 5 5
Reason Not Completed
Adverse Event             4             3
Lost to Follow-up             1             1
Withdrawal by Subject             0             1
Period Title: Weeks 13-16 / 40mg Dose Level
Started 113 113
Completed 108 111
Not Completed 5 2
Reason Not Completed
Adverse Event             3             2
Withdrawal by Subject             1             0
Per Sponsors Request             1             0
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 123 122 245
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 122 participants 245 participants
56.3  (9.64) 56.0  (10.84) 56.1  (10.23)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 122 participants 245 participants
Female
52
  42.3%
51
  41.8%
103
  42.0%
Male
71
  57.7%
71
  58.2%
142
  58.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants 122 participants 245 participants
White 108 110 218
Black or African American 6 4 10
Asian 8 4 12
American Indian or Alaskan Native 0 1 1
Native Hawaiian or Pacific Islander 0 1 1
Non-white 1 2 3
1.Primary Outcome
Title Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 121
Median (Inter-Quartile Range)
Unit of Measure: percent change
-40.2
(-45.3 to -32.5)
-33.7
(-39.6 to -28.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lovaza(Omacor) + Atorvastatin, Placebo + Atorvastatin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 121
Median (Inter-Quartile Range)
Unit of Measure: percent change
-31.5
(-36.0 to -25.3)
-27.4
(-31.7 to -22.2)
3.Secondary Outcome
Title Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description

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.

Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 121
Median (Inter-Quartile Range)
Unit of Measure: percent change
12.4
(3.6 to 22.9)
10.0
(-1.2 to 16.3)
4.Secondary Outcome
Title Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 120
Median (Inter-Quartile Range)
Unit of Measure: percent change
-29.3
(-41.1 to -18.4)
-31.5
(-41.4 to -23.4)
5.Secondary Outcome
Title Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Triglycerides - A naturally occurring ester of three fatty acids and glycerol that is the chief constituent of fats and oils.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 121
Median (Inter-Quartile Range)
Unit of Measure: percent change
-45.4
(-55.3 to -34.9)
-26.9
(-38.7 to -14.4)
6.Secondary Outcome
Title Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description VLDL - very-low-density lipoprotein: a plasma lipoprotein with a high lipid content, associated with atherosclerosis.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 120
Median (Inter-Quartile Range)
Unit of Measure: percent change
-54.3
(-66.7 to -36.7)
-37.0
(-50.9 to -17.8)
7.Secondary Outcome
Title Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Apolipoprotein A1 - major protein component of high density lipoprotein (HDL) in plasma. The protein promotes cholesterol efflux from tissues to the liver for excretion.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 121
Median (Inter-Quartile Range)
Unit of Measure: percent change
-0.3
(-7.0 to 9.0)
1.5
(-4.5 to 10.4)
8.Secondary Outcome
Title Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 119
Median (Inter-Quartile Range)
Unit of Measure: percent change
-29.4
(-36.8 to -17.4)
-16.0
(-27.3 to 0.0)
9.Secondary Outcome
Title Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Total cholesterol/High density lipoprotein cholesterol
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 121
Median (Inter-Quartile Range)
Unit of Measure: percent change
-38.3
(-44.9 to -31.9)
-34.5
(-40.3 to -25.0)
10.Secondary Outcome
Title Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description [Not Specified]
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 121
Median (Inter-Quartile Range)
Unit of Measure: percent change
-51.9
(-62.4 to -39.8)
-34.0
(-47.3 to -14.9)
11.Secondary Outcome
Title Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Docosahexaenoic Acid is an omega-3 essential fatty acid.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 101 103
Median (Inter-Quartile Range)
Unit of Measure: percent change
85.5
(49.4 to 125.6)
4.2
(-5.7 to 13.4)
12.Secondary Outcome
Title Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 101 103
Median (Inter-Quartile Range)
Unit of Measure: percent change
402.2
(276.8 to 570.8)
-5.6
(-20.0 to 14.9)
13.Secondary Outcome
Title Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
-34.6
(-42.9 to -24.0)
-32.2
(-41.2 to -23.5)
14.Secondary Outcome
Title Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
1.5
(-0.5 to 4.1)
0.5
(-1.0 to 2.0)
15.Secondary Outcome
Title Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Lipoprotein Phosphoslipase A2 - modified form of LDL.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
-20.7
(-27.5 to -10.0)
-9.7
(-17.6 to -0.6)
16.Secondary Outcome
Title Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
1.0
(-8.9 to 8.4)
5.1
(-1.3 to 11.9)
17.Secondary Outcome
Title Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
0.0
(-1.2 to 2.4)
1.2
(0.0 to 2.4)
18.Secondary Outcome
Title Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
-32.4
(-50.5 to -14.6)
-25.9
(-39.0 to -4.0)
19.Secondary Outcome
Title Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
-17.5
(-26.0 to -9.5)
-3.3
(-11.5 to 10.1)
20.Secondary Outcome
Title Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 114 112
Median (Inter-Quartile Range)
Unit of Measure: percent change
-60.4
(-87.9 to -18.6)
-50.3
(-77.2 to -20.5)
21.Secondary Outcome
Title Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Remnant-like particle cholesterol within the plasma has been identified as a cardiovascular risk factor.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 118 119
Median (Inter-Quartile Range)
Unit of Measure: percent change
-50.0
(-61.1 to -38.5)
-38.9
(-53.1 to -18.5)
22.Secondary Outcome
Title Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Adiponectin is a protein hormone that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 119 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
-5.1
(-15.2 to 8.2)
-1.6
(-12.6 to 7.7)
23.Secondary Outcome
Title Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 117 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
-46.9
(-52.2 to -40.1)
-39.0
(-45.3 to -33.5)
24.Secondary Outcome
Title Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period
Hide Description 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.
Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 113 112
Median (Inter-Quartile Range)
Unit of Measure: percent change
-50.4
(-57.6 to -43.3)
-46.3
(-51.7 to -40.3)
25.Post-Hoc Outcome
Title Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Hide Description Apolipoprotein B is the primary apolipoprotein of low density lipoproteins (LDL or "bad cholesterol"), which is responsible for carrying cholesterol to tissues.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 122 121
Median (Inter-Quartile Range)
Unit of Measure: percent change
-32.1
(-40.1 to -24.2)
-30.7
(-36.0 to -23.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   4   2 
Hepatobiliary disorders     
Cholecystitis Acute  1  0/122 (0.00%)  1/122 (0.82%) 
Infections and infestations     
Lobar Pneumonia  1  1/122 (0.82%)  0/122 (0.00%) 
Labyrinthitis  1  1/122 (0.82%)  0/122 (0.00%) 
Nervous system disorders     
Syncope  1  0/122 (0.00%)  1/122 (0.82%) 
Respiratory, thoracic and mediastinal disorders     
Chest Pain/ Dyspnea  1  1/122 (0.82%)  0/122 (0.00%) 
Vascular disorders     
Peripheral Ischemia  1  1/122 (0.82%)  0/122 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lovaza(Omacor) + Atorvastatin Placebo + Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/123 (0.00%)   0/122 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00435045     History of Changes
Other Study ID Numbers: OM9L
First Submitted: February 13, 2007
First Posted: February 14, 2007
Results First Submitted: October 22, 2008
Results First Posted: May 12, 2009
Last Update Posted: February 2, 2017