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™
Public ClinicalTrials.gov record NCT00891293. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00891293
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 93 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2006 (Type not available)
- Primary completion
- May 2008 (Actual)
- Completion
- May 2008 (Actual)
- Last update posted
- Jan 25, 2011
2006 – 2008
United States locations
- U.S. sites
- 32
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Spring Valley | California | 91978 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | — |
| GSK Investigational Site | Coral Gables | Florida | 33134 | — |
| GSK Investigational Site | Hollywood | Florida | 33023 | — |
| GSK Investigational Site | Jacksonville | Florida | 32216 | — |
| GSK Investigational Site | Jacksonville | Florida | 32259 | — |
| GSK Investigational Site | Longwood | Florida | 32779 | — |
| GSK Investigational Site | Pinellas Park | Florida | 33781 | — |
| GSK Investigational Site | Duhwoody | Georgia | 30338 | — |
| GSK Investigational Site | Chicago | Illinois | 60610 | — |
| GSK Investigational Site | Bloomington | Indiana | 47403 | — |
| GSK Investigational Site | Louisville | Kentucky | 40213 | — |
| GSK Investigational Site | Auburn | Maine | 04210 | — |
| GSK Investigational Site | Scarborough | Maine | 04074 | — |
| GSK Investigational Site | Baltimore | Maryland | 21209 | — |
| GSK Investigational Site | Wentzville | Minnesota | 62285 | — |
| GSK Investigational Site | Kansas City | Missouri | 64111 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Hickory | North Carolina | 28601 | — |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | — |
| GSK Investigational Site | Statesville | North Carolina | 28677 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27106 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45212 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| GSK Investigational Site | Cumberland | Rhode Island | 02864 | — |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | — |
| GSK Investigational Site | Bristol | Tennessee | 37620 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
| GSK Investigational Site | Richmond | Virginia | 23294 | — |
| GSK Investigational Site | Winchester | Virginia | 22601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00891293, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 25, 2011 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00891293 live on ClinicalTrials.gov.