Trial Outcomes & Findings for Epanova® for Lowering Very High Triglycerides (NCT NCT01242527)
NCT ID: NCT01242527
Last Updated: 2016-08-04
Results Overview
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
399 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-08-04
Participant Flow
The enrollment period started April 2011 and the last subject visit was February 2012. All subjects were qualified at the clinical site and eligibility was determined by each PI (74 US and International clinical sites).
Subjects who needed to washout omega-3 drugs/supplements or adjust or add a permitted statin, CAI or combination had an 8-week screening. All other subjects, including those on a stable statin, CAI or statin-CAI, or who needed to washout of bile acid sequestrants, fibrates, niacin and other lipid altering supplements had a 4-week screening period.
Participant milestones
| Measure |
Olive Oil (Placebo Control)
placebo : 4 capsules (1g) daily for 12 weeks
|
Epanova 2 g
omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
|
Epanova 3 g
omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
|
Epanova 4 g
omefas : 4 capsules (1g)daily for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
99
|
100
|
101
|
99
|
|
Overall Study
COMPLETED
|
94
|
93
|
87
|
90
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
14
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epanova® for Lowering Very High Triglycerides
Baseline characteristics by cohort
| Measure |
Olive Oil (Placebo)
n=99 Participants
placebo : 4 capsules (1g) daily for 12 weeks
|
Epanova 2 g
n=100 Participants
omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
|
Epanova 3 g
n=101 Participants
omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
|
Epanova 4 g
n=99 Participants
omefas : 4 capsules (1g)daily for 12 weeks
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.8 Years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
51.1 Years
STANDARD_DEVIATION 9.79 • n=7 Participants
|
51.2 Years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
52.9 Years
STANDARD_DEVIATION 10.92 • n=4 Participants
|
51.5 Years
STANDARD_DEVIATION 10.04 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
307 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
374 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented.
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups
Outcome measures
| Measure |
Olive Oil (Placebo)
n=98 Participants
placebo : 4 capsules (1g) daily for 12 weeks
|
Epanova 2 g
n=99 Participants
omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
|
Epanova 3 g
n=97 Participants
omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
|
Epanova 4 g
n=99 Participants
omefas : 4 capsules (1g)daily for 12 weeks
|
|---|---|---|---|---|
|
Fasting Serum Triglycerides
|
-4.26 Percent change from baseline
Interval -13.07 to 5.44
|
-25.94 Percent change from baseline
Interval -32.84 to -18.33
|
-25.46 Percent change from baseline
Interval -32.44 to -17.75
|
-30.86 Percent change from baseline
Interval -37.32 to -23.74
|
Adverse Events
Olive Oil (Placebo)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Epanova 2 g
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Epanova 3 g
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Epanova 4 g
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olive Oil (Placebo)
n=99 participants at risk
placebo : 4 capsules (1g) daily for 12 weeks
|
Epanova 2 g
n=100 participants at risk
omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
|
Epanova 3 g
n=101 participants at risk
omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
|
Epanova 4 g
n=99 participants at risk
omefas : 4 capsules (1g)daily for 12 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Myocarditis
|
1.0%
1/99 • Number of events 1
|
0.00%
0/100
|
0.00%
0/101
|
0.00%
0/99
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/99 • Number of events 1
|
0.00%
0/100
|
0.00%
0/101
|
0.00%
0/99
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/99
|
1.0%
1/100 • Number of events 1
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/99
|
0.00%
0/100
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/99
|
0.00%
0/100
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
|
Cardiac disorders
Implantable defibrillator insertion
|
0.00%
0/99
|
0.00%
0/100
|
0.99%
1/101 • Number of events 1
|
0.00%
0/99
|
Other adverse events
| Measure |
Olive Oil (Placebo)
n=99 participants at risk
placebo : 4 capsules (1g) daily for 12 weeks
|
Epanova 2 g
n=100 participants at risk
omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
|
Epanova 3 g
n=101 participants at risk
omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
|
Epanova 4 g
n=99 participants at risk
omefas : 4 capsules (1g)daily for 12 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/99 • Number of events 3
|
10.0%
10/100 • Number of events 12
|
5.9%
6/101 • Number of events 7
|
10.1%
10/99 • Number of events 11
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/99 • Number of events 1
|
6.0%
6/100 • Number of events 9
|
8.9%
9/101 • Number of events 11
|
5.1%
5/99 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
2/99 • Number of events 3
|
7.0%
7/100 • Number of events 7
|
3.0%
3/101 • Number of events 3
|
1.0%
1/99 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Individual investigators may publish data arising from their own subjects. The PI will provide the Sponsor with copies of written publications (including abstracts and posters)at least 60 days in advance of submission. Data will be reviewed by all participating investigators prior to publication. The Sponsor will have 60 days to review all definitive publications, such as manuscripts and book chapters, and a minimum of 30 days to review all abstracts.
- Publication restrictions are in place
Restriction type: OTHER