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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.

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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

FieldValue
Enrollment Target 13,078 participants
Start Date 2014-10-30
Est. Completion 2020-05-27
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.