Approval Probability
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Adjusted LOA
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omega-3-acid ethyl esters · 1 trial · 1 indication
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 refers to participants who did not have a documented episode of symptomatic AF or flutter.
| Arm | Type | Description |
|---|---|---|
| omega-3-acid ethyl esters | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| omega-3-acid ethyl esters | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Men and women age 18 years or older * History of symptomatic atrial fibrillation (either paroxysmal or persistent) * Provide written informed consent and authorization for protected health information disclosure Exclusion Criteria: * Permanent (chronic) atrial fibrillation *...
Omega-3-acid ethyl esters were studied as a treatment for recurrent, symptomatic atrial fibrillation, a heart rhythm disorder in which the upper chambers of the heart beat irregularly. The Phase 3 trial evaluated whether the drug reduced recurrence of symptomatic atrial fibrillation in adults aged 18 and older in the United States.
GSK plc, which trades under the ticker GSK, is the developer of omega-3-acid ethyl esters. The company sponsored the Phase 3 trial of the drug in recurrent, symptomatic atrial fibrillation, which was conducted at sites in the United States.
Omega-3-acid ethyl esters are in Phase 3 development for atrial fibrillation. The single registered trial, NCT00402363, has completed, and no trials are currently listed as active. The drug is investigational and is not described as approved for this indication.
One Phase 3 trial, NCT00402363, evaluated the efficacy and safety of omega-3-acid ethyl esters in recurrent, symptomatic atrial fibrillation. The completed study enrolled 663 participants aged 18 and older of all sexes, was randomized, double-blind, and placebo-controlled, and took place in the United States.
The Phase 3 trial NCT00402363 enrolled 663 participants. It was a randomized, double-blind, placebo-controlled study in adults with recurrent, symptomatic atrial fibrillation, and it has been completed. Enrollment was not restricted by sex, and participants were 18 years or older.