Trial · NCT03885661
Vascepa to Accelerate Lipoprotein Uptake and Elimination
NCT03885661, Phase 1, Completed, University of Pennsylvania; results first posted 2021-11-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vascepa to Accelerate Lipoprotein Uptake and Elimination. Trials, record NCT03885661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03885661
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vascepa to Accelerate Lipoprotein Uptake and Elimination
- NCT number
- NCT03885661
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Lipid Disorder, Triglycerides High, Dyslipidemias
- Interventions
- Icosapent Ethyl 1000 MG [Vascepa]
- First posted
- 2019-03-21
- Last updated
- 2021-11-11
- Results first posted
- 2021-11-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in VLDL-apoB100 Production Rate | ≥ 13 weeks of observation on randomized treatment assignment | The production rate of very low-density lipoprotein apolipoprotein B100 as determined by stable-isotope lipid kinetics techniques based on a primed constant infusion of deuterated leucine. |
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 | Change in VLDL-apoB100 Production Rate | ≥ 13 weeks of observation on randomized treatment assignment | All subjects who completed the ≥ 13 week treatment phase of the study (13-18 weeks). | mg VLDL apoB100 / kg body weight per day | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in VLDL-apoB100 Production Rate | Icosapent Ethyl | L apoB100 Production Rate (Baseline) | 21.7 | Standard Deviation 10.8 | mg VLDL apoB100 / kg body weight per day |
| Change in VLDL-apoB100 Production Rate | Usual Care | L apoB100 Production Rate (Baseline) | 14.9 | Standard Deviation 3.4 | mg VLDL apoB100 / kg body weight per day |
| Change in VLDL-apoB100 Production Rate | Icosapent Ethyl | VLDL apoB100 Production Rate (Treatment) | 21.3 | Standard Deviation 10.8 | mg VLDL apoB100 / kg body weight per day |
| Change in VLDL-apoB100 Production Rate | Usual Care | VLDL apoB100 Production Rate (Treatment) | 17.2 | Standard Deviation 8.5 | mg VLDL apoB100 / kg body weight per day |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Icosapent Ethyl | 12 | |
| Overall Study | STARTED | Usual Care | 8 | |
| Overall Study | Baseline | Icosapent Ethyl | 12 | |
| Overall Study | Baseline | Usual Care | 8 | |
| Overall Study | Treatment Visit (12 Week) | Icosapent Ethyl | 11 | |
| Overall Study | Treatment Visit (12 Week) | Usual Care | 7 | |
| Overall Study | COMPLETED | Icosapent Ethyl | 11 | |
| Overall Study | COMPLETED | Usual Care | 7 | |
| Overall Study | NOT COMPLETED | Icosapent Ethyl | 1 | |
| Overall Study | NOT COMPLETED | Usual Care | 1 |
Source ClinicalTrials.gov
Adverse events12
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 | Constipation; Dyspepsia; Nausea; Gastroenteritis | Gastrointestinal disorders | Icosapent Ethyl | 3 | 12 | 3 |
| other | Constipation; Dyspepsia; Nausea; Gastroenteritis | Gastrointestinal disorders | Usual Care | 2 | 8 | 2 |
| other | Headache; Migrane; Dizziness | Nervous system disorders | Icosapent Ethyl | 2 | 12 | 2 |
| other | Headache; Migrane; Dizziness | Nervous system disorders | Usual Care | 5 | 8 | 8 |
| other | Sinusitis; Itchy Throat | Respiratory, thoracic and mediastinal disorders | Icosapent Ethyl | 0 | 12 | 0 |
| other | Sinusitis; Itchy Throat | Respiratory, thoracic and mediastinal disorders | Usual Care | 2 | 8 | 3 |
| other | Limb discomfort; Joint pain | Musculoskeletal and connective tissue disorders | Icosapent Ethyl | 2 | 12 | 2 |
| other | Limb discomfort; Joint pain | Musculoskeletal and connective tissue disorders | Usual Care | 1 | 8 | 1 |
| other | Dermatitis; Urticaria | Skin and subcutaneous tissue disorders | Icosapent Ethyl | 2 | 12 | 2 |
| other | Dermatitis; Urticaria | Skin and subcutaneous tissue disorders | Usual Care | 0 | 8 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Icosapent Ethyl | 0 | 12 |
| Total, all-cause mortality | Usual Care | 0 | 8 |
| Total, other adverse events | Icosapent Ethyl | 8 | 12 |
| Total, other adverse events | Usual Care | 8 | 8 |
| Total, serious adverse events | Icosapent Ethyl | 0 | 12 |
| Total, serious adverse events | Usual Care | 0 | 8 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Icosapent Ethyl vs Usual Care: deaths from any cause | Trial comparisons |
| Icosapent Ethyl vs Usual Care: serious adverse events | 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/NCT03885661
GET https://conductscience.org/api/trials/v1/NCT03885661/registered