Trial · NCT01408303

[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL

NCT01408303, Phase 3, Completed, AstraZeneca; results first posted 2014-12-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. [E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL. Trials, record NCT01408303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01408303

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: [E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
NCT number: NCT01408303
Status: Completed
Phases: Phase 3
Enrollment: 646 participants, actual
Lead sponsor: AstraZeneca
Conditions: Hypertriglyceridemia, Cardiovascular Disease
Interventions: Olive oil, 4g, omega-3-carboxylic acids, 2g, omega-3-carboxylic acids, 4g
First posted: 2011-08-03
Last updated: 2014-12-05
Results first posted: 2014-12-05

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Serum Non-HDL Cholesterol	6 weeks	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Serum Non-HDL Cholesterol	6 weeks	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.	Percent change from baseline	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Serum Non-HDL Cholesterol	Epanova 2 g	-3.86	95% Confidence Interval -7.316 to -0.277	Percent change from baseline
Serum Non-HDL Cholesterol	Epanova 4 g	-6.91	95% Confidence Interval -10.204 to -3.504	Percent change from baseline
Serum Non-HDL Cholesterol	Placebo	-0.91	95% Confidence Interval -4.509 to 2.822	Percent change from baseline

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Epanova, 2 g + Statin	215
Overall Study	STARTED	Epanova, 4 g + Statin	216
Overall Study	STARTED	Olive Oil + Statin	216
Overall Study	COMPLETED	Epanova, 2 g + Statin	209
Overall Study	COMPLETED	Epanova, 4 g + Statin	204
Overall Study	COMPLETED	Olive Oil + Statin	210
Overall Study	NOT COMPLETED	Epanova, 2 g + Statin	6
Overall Study	NOT COMPLETED	Epanova, 4 g + Statin	12
Overall Study	NOT COMPLETED	Olive Oil + Statin	6

Source ClinicalTrials.gov

Adverse events27

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Epanova, 2 g	13	215	13
other	Diarrhea	Gastrointestinal disorders	Epanova, 4 g	36	216	36
other	Diarrhea	Gastrointestinal disorders	Placebo	5	215	5
other	Nausea	Gastrointestinal disorders	Epanova, 2 g	6	215	6
other	Nausea	Gastrointestinal disorders	Epanova, 4 g	13	216	13
other	Nausea	Gastrointestinal disorders	Placebo	3	215	3
serious	musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Epanova, 2 g	1	215	1
serious	musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Epanova, 4 g	0	216	0
serious	musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Placebo	0	215	0
serious	diverticular perforation	Gastrointestinal disorders	Epanova, 2 g	1	215	1

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Epanova, 2 g
Total, all-cause mortality	Epanova, 4 g
Total, all-cause mortality	Placebo
Total, other adverse events	Epanova, 2 g	13	215
Total, other adverse events	Epanova, 4 g	36	216
Total, other adverse events	Placebo	5	215
Total, serious adverse events	Epanova, 2 g	3	215
Total, serious adverse events	Epanova, 4 g	1	216
Total, serious adverse events	Placebo	3	215

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23998969	DERIVED	PubMed
26328624	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01408303

GET https://conductscience.org/api/trials/v1/NCT01408303/events?page=2

API reference For AI assistants