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AzTrials

Fibrillation, AtrialPhase 3NCT00402363

Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation

A Phase 3 study testing omega-3-acid ethyl esters in people with Fibrillation, Atrial, run by GlaxoSmithKline at 178 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibrillation, Atrial
What is being tested?
omega-3-acid ethyl esters
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
663 participants
Where
178 sitesUnited States
Study dates
Nov 2006to Jan 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Permanent (chronic) atrial fibrillation
  • Antiarrhythmic drug therapy which cannot be stopped
  • Use of amiodarone with prior 6 months
  • History of unsuccessful cardioversion
  • History of certain cardiovascular conditions or cardiac surgery within prior 6 months
  • History of stroke within prior 6 months
Show all 9Show fewer
  • Implanted cardio-defibrillator
  • Certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolic conditions, or cancer (except non-melanoma skin cancer)
  • Poorly controlled diabetes

Trial locations and contacts

178 sites in 1 country.

178 sites in 1 country

United States178 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Alamada, California, 94501

  • GSK Investigational Site

    Alpena, Michigan, 49707

  • GSK Investigational Site

    Anchorage, Alaska, 99508

  • GSK Investigational Site

    Annapolis, Maryland, 20401

  • GSK Investigational Site

    Arlington, Virginia, 22204

  • GSK Investigational Site

    Atlanta, Georgia, 30322

  • GSK Investigational Site

    Atlanta, Georgia, 30328

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Auburn, Maine, 04210

  • GSK Investigational Site

    Aurora, Colorado, 80012

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Ayer, Massachusetts, 01432

  • GSK Investigational Site

    Babylon, New York, 11702

  • GSK Investigational Site

    Bakersfield, California, 93301

  • GSK Investigational Site

    Bakersfield, California, 93308

  • GSK Investigational Site

    Bannockburn, Illinois, 60015

  • GSK Investigational Site

    Bay Pines, Florida, 33744

  • GSK Investigational Site

    Beaumont, Texas, 77702

  • GSK Investigational Site

    Beaver, Pennsylvania, 15009

  • GSK Investigational Site

    Beloit, Wisconsin, 53511

  • GSK Investigational Site

    Beverly Hills, California, 90210

  • GSK Investigational Site

    Biddeford, Maine, 04005

  • GSK Investigational Site

    Billings, Montana, 59101

  • GSK Investigational Site

    Birmingham, Alabama, 35215

  • GSK Investigational Site

    Bridgeport, Connecticut, 06606

  • GSK Investigational Site

    Brookline, Massachusetts, 02446

  • GSK Investigational Site

    Bryan, Ohio, 43506

  • GSK Investigational Site

    Buffalo, New York, 14209

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Burien, Washington, 98166

  • GSK Investigational Site

    Cadillac, Michigan, 49601

  • GSK Investigational Site

    Carmichael, California, 95608

  • GSK Investigational Site

    Charlotte, North Carolina, 28080

  • GSK Investigational Site

    Charlotte, North Carolina, 28203

  • GSK Investigational Site

    Chesapeake, Virginia, 23510

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Corpus Christi, Texas, 78404

  • GSK Investigational Site

    Corvalis, Oregon, 97330

  • GSK Investigational Site

    Cottonwood, Arizona, 86326

  • GSK Investigational Site

    Covington, Louisiana, 70433

  • GSK Investigational Site

    Cranston, Rhode Island, 02920

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Daytona Beach, Florida, 32114

  • GSK Investigational Site

    Decatur, Georgia, 30030

  • GSK Investigational Site

    Delray Beach, Florida, 33484

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Elkhart, Indiana, 46514

  • GSK Investigational Site

    Fair Oaks, California, 95628

  • GSK Investigational Site

    Fairview Park, Ohio, 44126

  • GSK Investigational Site

    Farmington, Connecticut, 06030

  • GSK Investigational Site

    Fort Meyers, Florida, 33919

  • GSK Investigational Site

    Fort Smith, Arkansas, 72901

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Gainesville, Florida, 32605

  • GSK Investigational Site

    Galax, Virginia, 24333

  • GSK Investigational Site

    Grand Forks, North Dakota, 58201

  • GSK Investigational Site

    Greensburg, Pennsylvania, 15601

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Guilford, Connecticut, 06437

  • GSK Investigational Site

    Gulfport, Mississippi, 39503

  • GSK Investigational Site

    Gurnee, Illinois, 60031

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Hillsboro, Oregon, 97123-4117

  • GSK Investigational Site

    Hot Springs, Arkansas, 71913

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Houston, Texas, 77090

  • GSK Investigational Site

    Hudson, Florida, 34667

  • GSK Investigational Site

    Humble, Texas, 77338

  • GSK Investigational Site

    Huntington, West Virginia, 25701

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Indianapolis, Indiana, 46260

  • GSK Investigational Site

    Jackson, Tennessee, 38301

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Jupiter, Florida, 33458

  • GSK Investigational Site

    Kalamazoo, Michigan, 49048

  • GSK Investigational Site

    Kalispell, Montana, 59901

  • GSK Investigational Site

    Kansas City, Kansas, 66102

  • GSK Investigational Site

    Kissimmee, Florida, 34741

  • GSK Investigational Site

    La Porte, Indiana, 46350

  • GSK Investigational Site

    Lacombe, Louisiana, 70445

  • GSK Investigational Site

    Langhorne, Pennsylvania, 19047

  • GSK Investigational Site

    Lansing, Michigan, 48910

  • GSK Investigational Site

    Largo, Florida, 33773

  • GSK Investigational Site

    Littleton, Colorado, 80120

  • GSK Investigational Site

    Loma Linda, California, 92354

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Los Angeles, California, 90073

  • GSK Investigational Site

    Los Angeles, California, 90211

  • GSK Investigational Site

    Louisville, Kentucky, 40205

  • GSK Investigational Site

    Lubbock, Texas, 79410

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    McKinney, Texas, 75069

  • GSK Investigational Site

    Melbourne, Florida, 32901

  • GSK Investigational Site

    Memphis, Tennessee, 38120

  • GSK Investigational Site

    Merced, California, 95348

  • GSK Investigational Site

    Mesa, Arizona, 85206

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Miami, Florida, 33137

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Mineappolis, Minnesota, 55417

  • GSK Investigational Site

    Mineola, New York, 11501

  • GSK Investigational Site

    Missoula, Montana, 59802

  • GSK Investigational Site

    Morristown, New Jersey, 07962

  • GSK Investigational Site

    Mount Sterling, Kentucky, 40353

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    New York, New York, 10025

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Odessa, Texas, 79761

  • GSK Investigational Site

    Odessa, Texas, 79764

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73109

  • GSK Investigational Site

    Orange, Texas, 77630

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Ormond Beach, Florida, 32174

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Pawtucket, Rhode Island, 02860

  • GSK Investigational Site

    Pensacola, Florida, 32514

  • GSK Investigational Site

    Peoria, Illinois, 61603

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19102

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Phoenix, Arizona, 85014

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Pinellas Park, Florida, 33781

  • GSK Investigational Site

    Portland, Maine, 04106

  • GSK Investigational Site

    Portland, Oregon, 97220

  • GSK Investigational Site

    Portland, Oregon, 97223

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    Redondo Beach, California, 90277

  • GSK Investigational Site

    Richlands, Virginia, 24641

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Ridley Park, Pennsylvania, 19078

  • GSK Investigational Site

    Rochester Hills, Minnesota, 48307

  • GSK Investigational Site

    Sacramento, California, 95819

  • GSK Investigational Site

    Saint Paul, Minnesota, 55102

  • GSK Investigational Site

    Salt Lake City, Utah, 84124

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    San Diego, California, 92161

  • GSK Investigational Site

    Scarborough, Maine, 04074

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105

  • GSK Investigational Site

    South Bend, Indiana, 46601

  • GSK Investigational Site

    Spartanburg, South Carolina, 29302

  • GSK Investigational Site

    Springfield, Virginia, 22151

  • GSK Investigational Site

    Statesville, North Carolina, 28625

  • GSK Investigational Site

    Summit, New Jersey, 07901

  • GSK Investigational Site

    Tampa, Florida, 33607

  • GSK Investigational Site

    Troy, New York, 12180

  • GSK Investigational Site

    Tucker, Georgia, 30084

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Tyler, Texas, 75701

  • GSK Investigational Site

    Vista, California, 92081

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20017

  • GSK Investigational Site

    Wausau, Wisconsin, 54401

  • GSK Investigational Site

    Wayne, New Jersey, 07470

  • GSK Investigational Site

    West Chester, Pennsylvania, 19380

  • GSK Investigational Site

    West Islip, New York, 11794

  • GSK Investigational Site

    Westerly, Rhode Island, 02891

  • GSK Investigational Site

    Worcester, Massachusetts, 01655

  • GSK Investigational Site

    Wynnewood, Pennsylvania, 19096

  • GSK Investigational Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Lovaza for the Prevention of 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.

Being tested
omega-3-acid ethyl esters, Placebo
Keywords
Lovaza, Omega-3 fatty acids, Omacor, Paroxysmal atrial fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • omega-3-acid ethyl estersDrug

  • PlaceboDrug

Study groups in NCT00402363
Study groupRoleWhat they receive
omega-3-acid ethyl estersExperimentalNot described
Receives: Drug: omega-3-acid ethyl esters
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter

    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.

    Measured: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)

Secondary outcomes (14)

  1. Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter

    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.

    Measured: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)

  2. Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)

    A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.

    Measured: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)

  3. Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)

    A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.

    Measured: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)

  4. Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter

    A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.

    Measured: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)

  5. Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter

    A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.

    Measured: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)

  6. Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)

    A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.

    Measured: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)

  7. Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)

    A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.

    Measured: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)

  8. Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter

    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. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.

    Measured: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)

  9. Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter

    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. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.

    Measured: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)

  10. Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)

    A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.

    Measured: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)

  11. Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)

    A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.

    Measured: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)

  12. Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period

    Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.

    Measured: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)

  13. Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period

    Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.

    Measured: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)

  14. Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period

    Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.

    Measured: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
663 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402363
Sponsor's protocol ID
OM8 Afib
Status last verified
Dec 2016
First submitted
20 Nov 2006
Last updated
30 Jan 2017
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Kowey PR, Reiffel JA, Ellenbogen KA, Naccarelli GV, Pratt CM. Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial. JAMA. 2010 Dec 1;304(21):2363-72. doi: 10.1001/jama.2010.1735. Epub 2010 Nov 15.

    PubMed 21078810

  • Pratt CM, Reiffel JA, Ellenbogen KA, Naccarelli GV, Kowey PR. Efficacy and safety of prescription omega-3-acid ethyl esters for the prevention of recurrent symptomatic atrial fibrillation: a prospective study. Am Heart J. 2009 Aug;158(2):163-169.e1-3. doi: 10.1016/j.ahj.2009.05.024.

    PubMed 19619690

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing omega-3-acid ethyl esters in people with Fibrillation, Atrial, run by GlaxoSmithKline at 178 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter (time frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402363, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.

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