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NCT00903409 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
NCT00903409: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00903409 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 188 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00903409, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)
Interventions
- DRUG Simvastatin + Lovaza® (omega-3-acid ethyl esters)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2005-11-15 |
| Est. Completion | 2008-06-27 |
| Phase | Phase 3 |
What the finished NCT00903409 record still lists
NCT00903409 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which Simvastatin + Lovaza® (omega-3-acid ethyl esters) is the first listed.
NCT00903409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00903409 about?
NCT00903409 is a clinical study titled "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". 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...
What is the current status of trial NCT00903409?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2005-11-15. Estimated completion is 2008-06-27.
What interventions are being tested in trial NCT00903409?
The interventions under investigation include: Simvastatin + Lovaza® (omega-3-acid ethyl esters) (DRUG).
Who is sponsoring clinical trial NCT00903409?
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 NCT00903409's enrollment target sits among peer trials
188 1408th of 2000 higher than 591 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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