Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00402363 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
A Phase 3 study of Fibrillation, Atrial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 663
- Enrollment target
- 20
- Study locations
NCT00402363: Completed Phase 3 study of Fibrillation, Atrial, sponsored by GlaxoSmithKline.
NCT00402363 is a Phase 3 study of Fibrillation, Atrial that has completed, run by GlaxoSmithKline. The registered enrollment target is 663 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00402363, a Phase 3 study of Fibrillation, Atrial, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 663 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
Primary Outcome
A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below re
Conditions Studied
Interventions
- DRUG Placebo
- DRUG omega-3-acid ethyl esters
Study Locations (20)
California
- GSK Investigational Site - Alamada
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Beverly Hills
- GSK Investigational Site - Carmichael
- GSK Investigational Site - Fair Oaks
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Loma Linda
- GSK Investigational Site - Los Angeles
Arizona
- GSK Investigational Site - Cottonwood
- GSK Investigational Site - Mesa
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tucson
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Huntsville
Arkansas
- GSK Investigational Site - Fort Smith
- GSK Investigational Site - Hot Springs
Alaska
- GSK Investigational Site - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 663 participants |
| Start Date | 2006-11 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00402363 record still lists
NCT00402363 is an interventional study that assigns participants to a tested intervention. The registered 663 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 (14% lower).
The record links to 1 condition, with Fibrillation, Atrial appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00402363 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT00402363 about?
NCT00402363 is a clinical study titled "Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation". The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
What is the current status of trial NCT00402363?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 663 participants. The study started on 2006-11. Estimated completion is 2010-01.
What conditions does trial NCT00402363 study?
This clinical trial studies the following conditions: Fibrillation, Atrial.
What interventions are being tested in trial NCT00402363?
The interventions under investigation include: Placebo (DRUG), omega-3-acid ethyl esters (DRUG).
Who is sponsoring clinical trial NCT00402363?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00402363 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00402363's enrollment target sits among peer trials
663 553rd of 2000 higher than 1,447 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07164443 · 663 participants · Phase 3
A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
- NCT06607341 · 664 participants · NA
Community Engagement Alliance Against Disparities
- NCT05254743 · 662 participants · Phase 3
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- NCT04064060 · 665 participants · Phase 3
A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia