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NCT02104817 · ClinicalTrials.gov registry record · Phase 3
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 13,078
- Enrollment target
NCT02104817: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02104817 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 13,078 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1596% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02104817, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13,078 participants
- Enrollment target
Study Summary
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
Primary Outcome
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Interventions
- DRUG Epanova® (omega-3 carboxylic acids)
- DRUG corn oil control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,078 participants |
| Start Date | 2014-10-30 |
| Est. Completion | 2020-05-27 |
| Phase | Phase 3 |
What the finished NCT02104817 record still lists
NCT02104817 is an interventional study that assigns participants to a tested intervention. Its 13,078 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1596% higher).
The record links to 0 conditions, and to 2 interventions - of which Epanova® (omega-3 carboxylic acids) is the first listed.
NCT02104817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02104817 about?
NCT02104817 is a clinical study titled "Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia". The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately...
What is the current status of trial NCT02104817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13,078 participants. The study started on 2014-10-30. Estimated completion is 2020-05-27.
What interventions are being tested in trial NCT02104817?
The interventions under investigation include: Epanova® (omega-3 carboxylic acids) (DRUG), corn oil control (DRUG).
Who is sponsoring clinical trial NCT02104817?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02104817's enrollment target sits among peer trials
13,078 17th of 2000 higher than 1,984 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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