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NCT00891293 · ClinicalTrials.gov registry record · Phase 4
A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 93
- Enrollment target
NCT00891293: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00891293 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 93 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00891293, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 93 participants
- Enrollment target
Study Summary
This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\] therapy in hypertriglyceridemic subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.
Primary Outcome
Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
Interventions
- DRUG Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-05 |
| Phase | Phase 4 |
What the finished NCT00891293 record still lists
NCT00891293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) is the first listed.
NCT00891293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00891293 about?
NCT00891293 is a clinical study titled "A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™". This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (f...
What is the current status of trial NCT00891293?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 93 participants. The study started on 2006-03. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00891293?
The interventions under investigation include: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) (DRUG).
Who is sponsoring clinical trial NCT00891293?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00891293's enrollment target sits among peer trials
93 874th of 2000 higher than 1,125 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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