Trial · NCT02009865
Epanova® for Lowering Very High Triglycerides II (EVOLVE II)
NCT02009865, Phase 3, Completed, AstraZeneca; results first posted 2016-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Epanova® for Lowering Very High Triglycerides II (EVOLVE II). Trials, record NCT02009865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02009865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Epanova® for Lowering Very High Triglycerides II (EVOLVE II)
- NCT number
- NCT02009865
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 379 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Hypertriglyceridemia
- Interventions
- Epanova, Olive Oil
- First posted
- 2013-12-12
- Last updated
- 2019-09-10
- Results first posted
- 2016-01-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Triglyceride for All Subjects | From Baseline to Week 12 Endpoint | This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate. |
| Secondary | Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL | From Baseline to Week 12 Endpoint | This first secondary endpoint in subjects with at least 1 qualifying triglyceride \>885 mg/dL was tested in parallel together with the primary endpoint, each at 0.025 Type I error rate. |
| Secondary | Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL) | From Baseline to Week 12 Endpoint | This secondary endpoint, together with the 3rd. and 4th secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure. |
| Secondary | Percent Change in High-Density Lipoprotein Cholesterol (mg/dL) | From Baseline to Week 12 Endpoint | This secondary endpoint, together with the 2nd. and 4th. secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure. |
| Secondary | Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6) | From Baseline to Week 12 Endpoint | This secondary endpoint in subjects with Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6), together with the 2nd. and 3rd.secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Triglyceride for All Subjects | From Baseline to Week 12 Endpoint | Full Analysis Set (FAS) | Percentage of change (%) | MEDIAN |
| SECONDARY | Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL | From Baseline to Week 12 Endpoint | FAS | Percentage of change (%) | MEDIAN |
| SECONDARY | Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL) | From Baseline to Week 12 Endpoint | FAS | Percentage of change (%) | MEDIAN |
| SECONDARY | Percent Change in High-Density Lipoprotein Cholesterol (mg/dL) | From Baseline to Week 12 Endpoint | FAS | Percentage of change (%) | MEDIAN |
| SECONDARY | Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6) | From Baseline to Week 12 Endpoint | FAS | Percentage of change (%) | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Triglyceride for All Subjects | Epanova | -28.1 | Inter-Quartile Range -42.1 to -5.5 | Percentage of change (%) | |
| Percent Change in Triglyceride for All Subjects | Olive Oil | -10.2 | Inter-Quartile Range -36.4 to 23.0 | Percentage of change (%) | |
| Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL | Epanova | -37.5 | Inter-Quartile Range -46.1 to -18.1 | Percentage of change (%) | |
| Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL | Olive Oil | -9.3 | Inter-Quartile Range -36.3 to 27 | Percentage of change (%) | |
| Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL) | Epanova | -8.8 | Inter-Quartile Range -15.7 to -1.4 | Percentage of change (%) | |
| Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL) | Olive Oil | 0.4 | Inter-Quartile Range -13.5 to 14.2 | Percentage of change (%) | |
| Percent Change in High-Density Lipoprotein Cholesterol (mg/dL) | Epanova | 3.4 | Inter-Quartile Range -5.1 to 12.5 | Percentage of change (%) | |
| Percent Change in High-Density Lipoprotein Cholesterol (mg/dL) | Olive Oil | 3.1 | Inter-Quartile Range -6.3 to 10.9 | Percentage of change (%) | |
| Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6) | Epanova | -24.7 | Inter-Quartile Range -43.3 to -2.8 | Percentage of change (%) | |
| Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6) | Olive Oil | -12.4 | Inter-Quartile Range -38.8 to 14.2 | Percentage of change (%) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Epanova | 81 | |
| Overall Study | STARTED | Olive Oil | 81 | |
| Overall Study | COMPLETED | Epanova | 80 | |
| Overall Study | COMPLETED | Olive Oil | 76 | |
| Overall Study | NOT COMPLETED | Epanova | 1 | |
| Overall Study | NOT COMPLETED | Olive Oil | 5 |
Source ClinicalTrials.gov
Adverse events178
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 | Epanova | 5 | 81 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Olive Oil | 5 | 81 | 6 |
| other | Eructation | Gastrointestinal disorders | Epanova | 3 | 81 | 3 |
| other | Eructation | Gastrointestinal disorders | Olive Oil | 0 | 81 | 0 |
| other | Constipation | Gastrointestinal disorders | Epanova | 2 | 81 | 2 |
| other | Constipation | Gastrointestinal disorders | Olive Oil | 0 | 81 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Epanova | 1 | 81 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Olive Oil | 1 | 81 | 1 |
| other | Flatulence | Gastrointestinal disorders | Epanova | 1 | 81 | 1 |
| other | Flatulence | Gastrointestinal disorders | Olive Oil | 0 | 81 | 0 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epanova | ||
| Total, all-cause mortality | Olive Oil | ||
| Total, other adverse events | Epanova | 29 | 81 |
| Total, other adverse events | Olive Oil | 28 | 81 |
| Total, serious adverse events | Epanova | 1 | 81 |
| Total, serious adverse events | Olive Oil | 2 | 81 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Epanova vs Olive Oil: serious adverse events |
Source Trial comparisons
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.
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/NCT02009865
GET https://conductscience.org/api/trials/v1/NCT02009865/events?page=2