Trial Outcomes & Findings for [E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL (NCT NCT01408303)
NCT ID: NCT01408303
Last Updated: 2014-12-05
Results Overview
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
646 participants
Primary outcome timeframe
6 weeks
Results posted on
2014-12-05
Participant Flow
The enrollment period started August 2011 and the last subject visit was May 2012. All subjects were qualified at the clinical site and eligibility was determined by each PI (96 sites)
Subjects underwent 6-week washout and diet stabilization period, discontinued use of any non-statin lipid therapies, continued their current statin regimen, and followed the NCEP TLC diet. Men and women considered to be at high risk for atherosclerotic CVD and who had high serum TG (≥200 mg/dL and \<500 mg/dL) were eligible for randomization.
Participant milestones
| Measure |
Epanova, 2 g + Statin
omega-3 carboxylic acids, 1 g capsule
omega-3 carboxylic acids + olive oil: omega-3 carboxylic acids 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks
prescribe statin
|
Epanova, 4 g + Statin
omega-3 carboxylic acids, 1 g capsule
omega-3 carboxylic acids: omega-3 carboxylic acids 4 x 1 g capsule daily for 6 weeks
prescribed statin
|
Olive Oil + Statin
olive oil, 1 g capsule
olive oil: 4 x 1 g capsule daily for 6 weeks
prescribed statin
|
|---|---|---|---|
|
Overall Study
STARTED
|
215
|
216
|
216
|
|
Overall Study
COMPLETED
|
209
|
204
|
210
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
6
|
Reasons for withdrawal
| Measure |
Epanova, 2 g + Statin
omega-3 carboxylic acids, 1 g capsule
omega-3 carboxylic acids + olive oil: omega-3 carboxylic acids 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks
prescribe statin
|
Epanova, 4 g + Statin
omega-3 carboxylic acids, 1 g capsule
omega-3 carboxylic acids: omega-3 carboxylic acids 4 x 1 g capsule daily for 6 weeks
prescribed statin
|
Olive Oil + Statin
olive oil, 1 g capsule
olive oil: 4 x 1 g capsule daily for 6 weeks
prescribed statin
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Noncompliance
|
1
|
0
|
1
|
Baseline Characteristics
[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
Baseline characteristics by cohort
| Measure |
Epanova, 2 g
n=215 Participants
omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
|
Epanova, 4 g
n=216 Participants
omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
|
Placebo
n=215 Participants
placebo, 1 g capsule
placebo : 4 x 1 g capsule daily for 6 weeks
|
Total
n=646 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
138 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
403 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
77 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
243 Participants
n=4 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 9.23 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 9.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
382 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
215 participants
n=5 Participants
|
216 participants
n=7 Participants
|
215 participants
n=5 Participants
|
646 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 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 non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.
Outcome measures
| Measure |
Epanova 2 g
n=209 Participants
omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo: omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
|
Epanova 4 g
n=207 Participants
omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
|
Placebo
n=211 Participants
placebo, 1 g capsule
placebo : 4 x 1 g capsule daily for 6 weeks
|
|---|---|---|---|
|
Serum Non-HDL Cholesterol
|
-3.86 Percent change from baseline
Interval -7.316 to -0.277
|
-6.91 Percent change from baseline
Interval -10.204 to -3.504
|
-0.91 Percent change from baseline
Interval -4.509 to 2.822
|
Adverse Events
Epanova, 2 g
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Epanova, 4 g
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epanova, 2 g
n=215 participants at risk
omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
|
Epanova, 4 g
n=216 participants at risk
omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
|
Placebo
n=215 participants at risk
placebo, 1 g capsule
placebo : 4 x 1 g capsule daily for 6 weeks
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.47%
1/215 • Number of events 1
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/216
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/215
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
|
Gastrointestinal disorders
diverticular perforation
|
0.47%
1/215 • Number of events 1
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/216
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/215
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.47%
1/215 • Number of events 1
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/216
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/215
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
|
Cardiac disorders
coronary artery disease
|
0.00%
0/215
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.46%
1/216 • Number of events 1
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/215
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
|
Infections and infestations
bronchitis
|
0.00%
0/215
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/216
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.47%
1/215 • Number of events 1
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.00%
0/215
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/216
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.47%
1/215 • Number of events 1
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/215
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.00%
0/216
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
0.47%
1/215 • Number of events 1
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
Other adverse events
| Measure |
Epanova, 2 g
n=215 participants at risk
omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
|
Epanova, 4 g
n=216 participants at risk
omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
|
Placebo
n=215 participants at risk
placebo, 1 g capsule
placebo : 4 x 1 g capsule daily for 6 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.0%
13/215 • Number of events 13
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
16.7%
36/216 • Number of events 36
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
2.3%
5/215 • Number of events 5
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
6/215 • Number of events 6
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
6.0%
13/216 • Number of events 13
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
1.4%
3/215 • Number of events 3
A total of 78 (12.1%) adverse events (AEs) were considered related to treatment: 13 in placebo, 21 in Epanova 2 g and 44 in Epanova 4 g. Twelve subjects (1.9%) had AEs causing discontinuation: 2 in placebo, 3 in Epanova 2 g and 7 in Epanova 4 g. Gastrointestinal disorders had the highest occurrence but most were mild or moderate and self-limiting.
|
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