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omega-3-acid ethyl esters

Phase 3

Fibrillation, Atrial | Small molecule | Cardiovascular |GSK plc|Last Updated: Jan 30, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment663

FDA Designations

No designations recorded

Clinical trial landscape

omega-3-acid ethyl esters · 1 trial · 1 indication

Phase 3 1
NCT00402363Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial FibrillationFibrillation, Atrial
COMPLETED663 Analytics
PHASE3COMPLETED
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
Fibrillation, Atrial
NCT00402363663
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Study Endpoints

Primary Endpoints

Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)

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.

Secondary Endpoints

Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
omega-3-acid ethyl estersEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
omega-3-acid ethyl estersDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites178

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 *...

Countries:United States
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