Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Public ClinicalTrials.gov record NCT00903409. 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.
Official title
OM6X: An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza (Previously Omacor®) and Simvastatin Therapy in Hypertriglyceridemic Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) \[formerly known as Omacor\] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
Study identification
- NCT ID
- NCT00903409
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 188 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
- Nov 15, 2005 (Actual)
- Primary completion
- Jun 27, 2008 (Actual)
- Completion
- Jun 27, 2008 (Actual)
- Last update posted
- Oct 9, 2017
2005 – 2008
United States locations
- U.S. sites
- 40
- U.S. states
- 19
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36608 | — |
| GSK Investigational Site | Encinitas | California | 92024 | — |
| GSK Investigational Site | Fresno | California | 93710 | — |
| GSK Investigational Site | Greenbrae | California | 94904 | — |
| GSK Investigational Site | Sacramento | California | 95831 | — |
| GSK Investigational Site | Thousand Oaks | California | 91360 | — |
| GSK Investigational Site | Hollywood | Florida | 33023 | — |
| GSK Investigational Site | Pinellas Park | Florida | 33781 | — |
| GSK Investigational Site | Tampa | Florida | 33606 | — |
| GSK Investigational Site | Atlanta | Georgia | 30309 | — |
| GSK Investigational Site | Dunwoody | Georgia | 30328 | — |
| GSK Investigational Site | Suwanee | Georgia | 30024 | — |
| GSK Investigational Site | Chicago | Illinois | 60610 | — |
| GSK Investigational Site | Bloomington | Indiana | 47403 | — |
| GSK Investigational Site | Evansville | Indiana | 47714 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | — |
| GSK Investigational Site | Louisville | Kentucky | 40213 | — |
| GSK Investigational Site | Baltimore | Maryland | 21209 | — |
| GSK Investigational Site | Edina | Minnesota | 55435 | — |
| GSK Investigational Site | Wentzville | Minnesota | 62285 | — |
| GSK Investigational Site | Kansas City | Missouri | 64111 | — |
| GSK Investigational Site | New York | New York | 10032 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | — |
| GSK Investigational Site | Hickory | North Carolina | 28601 | — |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | — |
| GSK Investigational Site | Statesville | North Carolina | 28677 | — |
| GSK Investigational Site | Wilmington | North Carolina | 28412 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27106 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45212 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45246 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | — |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | — |
| GSK Investigational Site | Bristol | Tennessee | 37620 | — |
| GSK Investigational Site | Plano | Texas | 75093 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
| GSK Investigational Site | Richmond | Virginia | 23249 | — |
| GSK Investigational Site | Richmond | Virginia | 23294 | — |
| GSK Investigational Site | Lakewood | Washington | 98499 | — |
| GSK Investigational Site | Seattle | Washington | 98104 | — |
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 NCT00903409, 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 Oct 9, 2017 · 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 NCT00903409 live on ClinicalTrials.gov.