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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 188 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00903409
The ClinicalTrials.gov registry entry for NCT00903409 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 188 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 Simvastatin + Lovaza® (omega-3-acid ethyl esters) is the first listed.
NCT00903409 reports 0 study locations.
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.
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