Trial · NCT02189252
An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis
NCT02189252, Phase 1, Completed, AstraZeneca; results first posted 2016-06-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis. Trials, record NCT02189252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02189252
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis
- NCT number
- NCT02189252
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- Epanova, Lovaza
- First posted
- 2014-07-14
- Last updated
- 2016-06-20
- Results first posted
- 2016-06-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal |
| Primary | Baseline-adjusted Cmax for Plasma Total EPA + Total DHA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | Cmax: Maximum measured plasma concentration over the time span specified |
| Secondary | Baseline-adjusted AUC0-24 for Plasma Total EPA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | |
| Secondary | Baseline-adjusted Cmax for Plasma Total EPA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | |
| Secondary | Baseline-adjusted AUC0-24 for Plasma Total DHA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | |
| Secondary | Baseline-adjusted Cmax for Plasma Total DHA | This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between. | |
| Secondary | Baseline-adjusted AUC0-24 for Plasma Total DPA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | |
| Secondary | Baseline-adjusted Cmax for Plasma Total DPA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | PK population | hr*nmol/mL | GEOMETRIC_MEAN |
| PRIMARY | Baseline-adjusted Cmax for Plasma Total EPA + Total DHA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | PK population | nmol/mL | GEOMETRIC_MEAN |
| SECONDARY | Baseline-adjusted AUC0-24 for Plasma Total EPA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | PK Population | hr*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Baseline-adjusted Cmax for Plasma Total EPA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | PK Population | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Baseline-adjusted AUC0-24 for Plasma Total DHA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | PK Population | hr*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Baseline-adjusted Cmax for Plasma Total DHA | This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between. | PK Population | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Baseline-adjusted AUC0-24 for Plasma Total DPA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | PK Population | hr*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Baseline-adjusted Cmax for Plasma Total DPA | participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. | PK Population | ug/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA | Epanova 2 g | 17000 | Geometric Coefficient of Variation 121.7 | hr*nmol/mL | |
| Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA | Epanova 4 g | 18000 | Geometric Coefficient of Variation 104.6 | hr*nmol/mL | |
| Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA | Lovaza 4 g | 12500 | Geometric Coefficient of Variation 80.0 | hr*nmol/mL | |
| Baseline-adjusted Cmax for Plasma Total EPA + Total DHA | Epanova 2 g | 1090 | Geometric Coefficient of Variation 78.6 | nmol/mL | |
| Baseline-adjusted Cmax for Plasma Total EPA + Total DHA | Epanova 4 g | 1200 | Geometric Coefficient of Variation 70.2 | nmol/mL | |
| Baseline-adjusted Cmax for Plasma Total EPA + Total DHA | Lovaza 4 g | 712 | Geometric Coefficient of Variation 76.7 | nmol/mL | |
| Baseline-adjusted AUC0-24 for Plasma Total EPA | Epanova 2 g | 3510 | Geometric Coefficient of Variation 117.8 | hr*ug/mL | |
| Baseline-adjusted AUC0-24 for Plasma Total EPA | Epanova 4 g | 3930 | Geometric Coefficient of Variation 83.0 | hr*ug/mL | |
| Baseline-adjusted AUC0-24 for Plasma Total EPA | Lovaza 4 g | 1730 | Geometric Coefficient of Variation 78.4 | hr*ug/mL | |
| Baseline-adjusted Cmax for Plasma Total EPA | Epanova 2 g | 221 | Geometric Coefficient of Variation 83.0 | ug/mL |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Visit 4b, Week 4) | STARTED | Treatment Sequence 1 | 4 | |
| Period 1 (Visit 4b, Week 4) | STARTED | Treatment Sequence 2 | 4 | |
| Period 1 (Visit 4b, Week 4) | STARTED | Treatment Sequence 3 | 3 | |
| Period 1 (Visit 4b, Week 4) | STARTED | Treatment Sequence 4 | 4 | |
| Period 1 (Visit 4b, Week 4) | COMPLETED | Treatment Sequence 1 | 4 | |
| Period 1 (Visit 4b, Week 4) | COMPLETED | Treatment Sequence 2 | 2 | |
| Period 1 (Visit 4b, Week 4) | COMPLETED | Treatment Sequence 3 | 3 | |
| Period 1 (Visit 4b, Week 4) | COMPLETED | Treatment Sequence 4 | 4 | |
| Period 1 (Visit 4b, Week 4) | NOT COMPLETED | Treatment Sequence 1 | 0 | |
| Period 1 (Visit 4b, Week 4) | NOT COMPLETED | Treatment Sequence 2 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events210
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 | Any | Blood and lymphatic system disorders | Epanova 2 g (I) | 0 | 3 | |
| other | Any | Blood and lymphatic system disorders | Epanova 4 g (I) | 0 | 4 | |
| other | Any | Blood and lymphatic system disorders | Lovaza 4 g (I) | 1 | 8 | |
| other | Any | Blood and lymphatic system disorders | Epanova 2 g (II) | 0 | 4 | |
| other | Any | Blood and lymphatic system disorders | Epanova 4 g (II) | 0 | 2 | |
| other | Any | Blood and lymphatic system disorders | Lovaza 4 g (II) | 0 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Epanova 2 g (I) | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Epanova 4 g (I) | 0 | 4 | |
| other | Anemia | Blood and lymphatic system disorders | Lovaza 4 g (I) | 1 | 8 | |
| other | Anemia | Blood and lymphatic system disorders | Epanova 2 g (II) | 0 | 4 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epanova 2 g (I) | ||
| Total, all-cause mortality | Epanova 4 g (I) | ||
| Total, all-cause mortality | Lovaza 4 g (I) | ||
| Total, all-cause mortality | Epanova 2 g (II) | ||
| Total, all-cause mortality | Epanova 4 g (II) | ||
| Total, all-cause mortality | Lovaza 4 g (II) | ||
| Total, other adverse events | Epanova 2 g (I) | 2 | 3 |
| Total, other adverse events | Epanova 4 g (I) | 3 | 4 |
| Total, other adverse events | Lovaza 4 g (I) | 5 | 8 |
| Total, other adverse events | Epanova 2 g (II) | 3 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32473640 | 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.
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/NCT02189252
GET https://conductscience.org/api/trials/v1/NCT02189252/results?page=2