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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 13,078 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02104817
The ClinicalTrials.gov registry entry for NCT02104817 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 13,078 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Epanova® (omega-3 carboxylic acids) is the first listed.
NCT02104817 reports 0 study locations.
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.
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