Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 93 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00891293
The ClinicalTrials.gov registry entry for NCT00891293 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.