Trial · NCT01242527

Epanova® for Lowering Very High Triglycerides

NCT01242527, Phase 2, Phase 3, Completed, AstraZeneca; results first posted 2013-09-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Epanova® for Lowering Very High Triglycerides. Trials, record NCT01242527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01242527

On this page

Trial

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

Title: Epanova® for Lowering Very High Triglycerides
NCT number: NCT01242527
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 399 participants, actual
Lead sponsor: AstraZeneca
Conditions: Severe Hypertriglyceridemia
Interventions: placebo, omefas, omefas, omefas
First posted: 2010-11-17
Last updated: 2016-08-04
Results first posted: 2013-09-06

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Fasting Serum Triglycerides	12 weeks	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

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	Fasting Serum Triglycerides	12 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 group4

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

Outcome	Group	Value	Spread	Units
Fasting Serum Triglycerides	Olive Oil (Placebo)	-4.26	95% Confidence Interval -13.07 to 5.44	Percent change from baseline
Fasting Serum Triglycerides	Epanova 2 g	-25.94	95% Confidence Interval -32.84 to -18.33	Percent change from baseline
Fasting Serum Triglycerides	Epanova 3 g	-25.46	95% Confidence Interval -32.44 to -17.75	Percent change from baseline
Fasting Serum Triglycerides	Epanova 4 g	-30.86	95% Confidence Interval -37.32 to -23.74	Percent change from baseline

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Olive Oil (Placebo Control)	99
Overall Study	STARTED	Epanova 2 g	100
Overall Study	STARTED	Epanova 3 g	101
Overall Study	STARTED	Epanova 4 g	99
Overall Study	COMPLETED	Olive Oil (Placebo Control)	94
Overall Study	COMPLETED	Epanova 2 g	93
Overall Study	COMPLETED	Epanova 3 g	87
Overall Study	COMPLETED	Epanova 4 g	90
Overall Study	NOT COMPLETED	Olive Oil (Placebo Control)	5
Overall Study	NOT COMPLETED	Epanova 2 g	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events36

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	Diarrhoea	Gastrointestinal disorders	Olive Oil (Placebo)	2	99	3
other	Diarrhoea	Gastrointestinal disorders	Epanova 2 g	10	100	12
other	Diarrhoea	Gastrointestinal disorders	Epanova 3 g	6	101	7
other	Diarrhoea	Gastrointestinal disorders	Epanova 4 g	10	99	11
other	Nausea	Gastrointestinal disorders	Olive Oil (Placebo)	1	99	1
other	Nausea	Gastrointestinal disorders	Epanova 2 g	6	100	9
other	Nausea	Gastrointestinal disorders	Epanova 3 g	9	101	11
other	Nausea	Gastrointestinal disorders	Epanova 4 g	5	99	5
other	Nasopharyngitis	Infections and infestations	Olive Oil (Placebo)	2	99	3
other	Nasopharyngitis	Infections and infestations	Epanova 2 g	7	100	7

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Olive Oil (Placebo)
Total, all-cause mortality	Epanova 2 g
Total, all-cause mortality	Epanova 3 g
Total, all-cause mortality	Epanova 4 g
Total, other adverse events	Olive Oil (Placebo)	5	99
Total, other adverse events	Epanova 2 g	23	100
Total, other adverse events	Epanova 3 g	18	101
Total, other adverse events	Epanova 4 g	16	99
Total, serious adverse events	Olive Oil (Placebo)	2	99
Total, serious adverse events	Epanova 2 g	1	100

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24528690	DERIVED

Source 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/NCT01242527

GET https://conductscience.org/api/trials/v1/NCT01242527/events?page=2

API reference For AI assistants