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An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis (ECLIPSEIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189252
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Severe Hypertriglyceridemia
Interventions Drug: Epanova
Drug: Lovaza
Enrollment 30
Recruitment Details The study subjects were recruited at 6 sites. In total, 30 subjects were screened, of which 15 were randomized to 1 of 4 treatment sequences.
Pre-assignment Details No applicable
Arm/Group Title Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4
Hide Arm/Group Description Epanova 4g per day: Lovaza 4g per day Lovaza 4 g per day:Epanova 4 g per day : 4 subjects Epanova 2g per day:Lovaza 4g per day: Lovaza 4g per day:Epanova 2g per day:
Period Title: Period 1 (Visit 4b, Week 4)
Started 4 4 3 4
Completed 4 2 3 4
Not Completed 0 2 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Adverse Event             0             1             0             0
Period Title: Period 2 (Visit6b, Week 12)
Started 4 2 3 4
Completed 4 2 3 4
Not Completed 0 0 0 0
Arm/Group Title Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4 Total
Hide Arm/Group Description Epanova 4 g per day:Lovaza 4 g per day Lovaza 4 g per day:Epanova 4 g per day : 4 subjects Epanova 2 g per day:Lovaza 4 g per day Lovaza 4 g per day:Epanova 2 g per day: 4 subjects Total of all reporting groups
Overall Number of Baseline Participants 4 4 3 4 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
47.5  (6.86) 46.0  (13.09) 53.0  (16.46) 53.5  (11.27) 49.8  (11.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 3 participants 4 participants 15 participants
Female
1
  25.0%
3
  75.0%
1
  33.3%
0
   0.0%
5
  33.3%
Male
3
  75.0%
1
  25.0%
2
  66.7%
4
 100.0%
10
  66.7%
1.Primary Outcome
Title Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA
Hide Description AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
Time Frame participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Epanova 2 g Epanova 4 g Lovaza 4 g
Hide Arm/Group Description:
Once daily (QD)
Once daily (QD)
Once daily (QD)
Overall Number of Participants Analyzed 6 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*nmol/mL
17000
(121.7%)
18000
(104.6%)
12500
(80.0%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova 4 g, Lovaza 4 g
Comments In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value>0.05). This is the first test in the fixed testing sequence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2702
Comments The closed sequential testing procedure stopped at this step as the P Value is greater than 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 160.05
Confidence Interval (2-Sided) 95%
64.71 to 395.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Epanova 2 g, Lovaza 4 g
Comments In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value>0.05). This is the second test in the fixed testing sequence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6367
Comments The p-value was only interpreted descriptively
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 121.61
Confidence Interval (2-Sided) 95%
49.17 to 300.76
Estimation Comments [Not Specified]
2.Primary Outcome
Title Baseline-adjusted Cmax for Plasma Total EPA + Total DHA
Hide Description Cmax: Maximum measured plasma concentration over the time span specified
Time Frame participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Epanova 2 g Epanova 4 g Lovaza 4 g
Hide Arm/Group Description:
Once daily (QD)
Once daily (QD)
Once daily (QD)
Overall Number of Participants Analyzed 6 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/mL
1090
(78.6%)
1200
(70.2%)
712
(76.7%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova 4 g, Lovaza 4 g
Comments In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value>0.05). This is the third test in the fixed testing sequence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0511
Comments The p-value was only interpreted descriptively
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 193.91
Confidence Interval (2-Sided) 95%
99.61 to 377.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Epanova 2 g, Lovaza 4 g
Comments In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value>0.05). This is the fourth test in the fixed testing sequence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3543
Comments The p-value was only interpreted descriptively
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 133.32
Confidence Interval (2-Sided) 95%
68.49 to 259.52
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Baseline-adjusted AUC0-24 for Plasma Total EPA
Hide Description [Not Specified]
Time Frame participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Epanova 2 g Epanova 4 g Lovaza 4 g
Hide Arm/Group Description:
Once daily (QD)
Once daily (QD)
Once daily (QD)
Overall Number of Participants Analyzed 6 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ug/mL
3510
(117.8%)
3930
(83.0%)
1730
(78.4%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova 4 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0210
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 259.19
Confidence Interval (2-Sided) 95%
119.75 to 560.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Epanova 2 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1256
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 177.95
Confidence Interval (2-Sided) 95%
82.22 to 385.16
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Baseline-adjusted Cmax for Plasma Total EPA
Hide Description [Not Specified]
Time Frame participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Epanova 2 g Epanova 4 g Lovaza 4 g
Hide Arm/Group Description:
Once daily (QD)
Once daily (QD)
Once daily (QD)
Overall Number of Participants Analyzed 6 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
221
(83.0%)
255
(65.7%)
100
(74.9%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova 4 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments The p-value was only interpreted descriptively
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 298.91
Confidence Interval (2-Sided) 95%
164.32 to 543.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Epanova 2 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0418
Comments The p-value was only interpreted descriptively
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 187.28
Confidence Interval (2-Sided) 95%
102.95 to 340.66
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Baseline-adjusted AUC0-24 for Plasma Total DHA
Hide Description [Not Specified]
Time Frame participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Epanova 2 g Epanova 4 g Lovaza 4 g
Hide Arm/Group Description:
Once daily (QD)
Once daily (QD)
Once daily (QD)
Overall Number of Participants Analyzed 6 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ug/mL
1710
(136.3%)
1550
(195.2%)
2190
(86.9%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova 4 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6833
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 79.36
Confidence Interval (2-Sided) 95%
22.95 to 274.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Epanova 2 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5220
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 69.39
Confidence Interval (2-Sided) 95%
20.07 to 239.98
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Baseline-adjusted Cmax for Plasma Total DHA
Hide Description [Not Specified]
Time Frame This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Epanova 2 g Epanova 4 g Lovaza 4 g
Hide Arm/Group Description:
Once daily (QD)
Once daily (QD)
Once daily (QD)
Overall Number of Participants Analyzed 6 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
116
(76.1%)
118
(89.2%)
128
(82.3%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova 4 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9034
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 104.78
Confidence Interval (2-Sided) 95%
44.92 to 244.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Epanova 2 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5782
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 80.58
Confidence Interval 95%
34.55 to 187.95
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Baseline-adjusted AUC0-24 for Plasma Total DPA
Hide Description [Not Specified]
Time Frame participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Epanova 2 g Epanova 4 g Lovaza 4 g
Hide Arm/Group Description:
Once daily (QD)
Once daily (QD)
Once daily (QD)
Overall Number of Participants Analyzed 6 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ug/mL
244
(225.3%)
380
(240.9%)
108
(374.3%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova 4 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0391
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 753.75
Confidence Interval (2-Sided) 95%
112.03 to 5071.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Epanova 2 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9578
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 104.98
Confidence Interval (2-Sided) 95%
15.60 to 706.33
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Baseline-adjusted Cmax for Plasma Total DPA
Hide Description [Not Specified]
Time Frame participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Epanova 2 g Epanova 4 g Lovaza 4 g
Hide Arm/Group Description:
Once daily (QD)
Once daily (QD)
Once daily (QD)
Overall Number of Participants Analyzed 6 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
23.0
(64.2%)
26.4
(83.3%)
11.1
(128.9%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epanova 4 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0186
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 376.64
Confidence Interval (2-Sided) 95%
128.55 to 1103.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Epanova 2 g, Lovaza 4 g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5955
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio in %
Estimated Value 131.74
Confidence Interval (2-Sided) 95%
44.97 to 386.00
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epanova 2 g (I) Epanova 4 g (I) Lovaza 4 g (I) Epanova 2 g (II) Epanova 4 g (II) Lovaza 4 g (II)
Hide Arm/Group Description Treatment period I Treatment period I Treatment period I Treatment period II Treatment period II Treatment period II
All-Cause Mortality
Epanova 2 g (I) Epanova 4 g (I) Lovaza 4 g (I) Epanova 2 g (II) Epanova 4 g (II) Lovaza 4 g (II)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Epanova 2 g (I) Epanova 4 g (I) Lovaza 4 g (I) Epanova 2 g (II) Epanova 4 g (II) Lovaza 4 g (II)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/4 (0.00%)   0/8 (0.00%)   0/4 (0.00%)   0/2 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epanova 2 g (I) Epanova 4 g (I) Lovaza 4 g (I) Epanova 2 g (II) Epanova 4 g (II) Lovaza 4 g (II)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   3/4 (75.00%)   5/8 (62.50%)   3/4 (75.00%)   2/2 (100.00%)   1/7 (14.29%) 
Blood and lymphatic system disorders             
Any  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Anemia  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Gastrointestinal disorders             
Any  1  2/3 (66.67%)  2/4 (50.00%)  2/8 (25.00%)  2/4 (50.00%)  1/2 (50.00%)  0/7 (0.00%) 
Diarrhea  1  1/3 (33.33%)  1/4 (25.00%)  0/8 (0.00%)  1/4 (25.00%)  1/2 (50.00%)  0/7 (0.00%) 
Nausea  1  1/3 (33.33%)  1/4 (25.00%)  1/8 (12.50%)  1/4 (25.00%)  0/2 (0.00%)  0/7 (0.00%) 
Abdominal distension  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Abdominal pain  1  0/3 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/2 (50.00%)  0/7 (0.00%) 
Dyspepsia  1  1/3 (33.33%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
General disorders             
Any  1  0/3 (0.00%)  1/4 (25.00%)  3/8 (37.50%)  2/4 (50.00%)  0/2 (0.00%)  0/7 (0.00%) 
Local swelling  1  0/3 (0.00%)  0/4 (0.00%)  2/8 (25.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Asthenia  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Pyrexia  1  0/3 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Fatigue  1  0/3 (0.00%)  0/4 (0.00%)  2/8 (25.00%)  2/4 (50.00%)  0/2 (0.00%)  0/7 (0.00%) 
Infections and infestations             
Any  1  1/3 (33.33%)  2/4 (50.00%)  0/8 (0.00%)  1/4 (25.00%)  1/2 (50.00%)  0/7 (0.00%) 
Abdominal abscess  1  0/3 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Bronchitis  1  0/3 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Influenza  1  0/3 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/7 (0.00%) 
Nasopharyngitis  1  1/3 (33.33%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Pharyngitis streptococcal  1  0/3 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Viral upper respiratory tract infection  1  0/3 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/2 (50.00%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders             
Any  1  0/3 (0.00%)  1/4 (25.00%)  2/8 (25.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Back pain  1  0/3 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Myopathy  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Pain in extremity  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Nervous system disorders             
Any  1  0/3 (0.00%)  1/4 (25.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  1/7 (14.29%) 
Headache  1  0/3 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Lethargy  1  0/3 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/7 (14.29%) 
Somnolence  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders             
Any  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Renal failure  1  0/3 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Any  1  1/3 (33.33%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Epistaxis  1  1/3 (33.33%)  0/4 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders             
Any  1  0/3 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/7 (0.00%) 
Xanthelasma  1  0/3 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/7 (0.00%) 
Xanthoma  1  0/3 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/7 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
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Name/Title: Hong Yang, Study Statistician
Organization: AstraZeneca AB
Phone: +46-(0)317762397
EMail: hong.yang1@astrazeneca.com
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02189252    
Other Study ID Numbers: D5880C00003
OM-EPA-013 ( Other Identifier: Omthera )
First Submitted: June 23, 2014
First Posted: July 14, 2014
Results First Submitted: March 29, 2016
Results First Posted: June 20, 2016
Last Update Posted: June 20, 2016