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NCT01208961 · ClinicalTrials.gov registry record · Phase 2

Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation

A Phase 2 study of Severe Hypertriglyceridemia, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target
1
Study location

NCT01208961: Completed Phase 2 study of Severe Hypertriglyceridemia, sponsored by AstraZeneca.

NCT01208961 is a Phase 2 study of Severe Hypertriglyceridemia that has completed, run by AstraZeneca. The registered enrollment target is 54 participants, below the 418-participant average among 8 other Severe Hypertriglyceridemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01208961, a Phase 2 study of Severe Hypertriglyceridemia, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.

Primary Outcome

Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.

Interventions

  • DRUG Epanova (4 g) and Lovaza (4 g)
  • DRUG Lovaza (4 g) and Epanova (4 g)

Study Locations (1)

Illinois

  • Radiant Research - Chicago

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2010-09
Est. Completion 2010-11
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT01208961 record still lists

NCT01208961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 418-participant average among 8 other Severe Hypertriglyceridemia trials with a reported enrollment target (87% lower).

The record links to 1 condition, with Severe Hypertriglyceridemia appearing as the primary indexed condition, and to 2 interventions - of which Epanova (4 g) and Lovaza (4 g) is the first listed.

NCT01208961 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT01208961 about?

NCT01208961 is a clinical study titled "Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation". The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.

What is the current status of trial NCT01208961?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2010-09. Estimated completion is 2010-11.

What conditions does trial NCT01208961 study?

This clinical trial studies the following conditions: Severe Hypertriglyceridemia.

What interventions are being tested in trial NCT01208961?

The interventions under investigation include: Epanova (4 g) and Lovaza (4 g) (DRUG), Lovaza (4 g) and Epanova (4 g) (DRUG).

Who is sponsoring clinical trial NCT01208961?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01208961 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Severe Hypertriglyceridemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01208961's enrollment target sits among peer trials

54 9th of 8 the lowest of 8 other Severe Hypertriglyceridemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Severe Hypertriglyceridemia 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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Source: ClinicalTrials.gov NCT01208961, the US trial registry maintained by the National Library of Medicine. NCT01208961 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.