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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omega-3-acid ethyl esters | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3-acid ethyl esters | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35215 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21078810 | Result | 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. | |
| 19619690 | Derived |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| OM8 Afib | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paroxysmal AF, P-OM3 | Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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) | 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. | 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) | 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. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) |
| 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. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) |
| 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. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) |
| 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. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) |
| 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. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) |
| 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. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) |
| 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. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) |
| 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. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) |
| 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. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) |
| 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. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) |
| 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. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) |
| 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. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| GSK Investigational Site | Anchorage | Alaska | 99508 | United States |
| GSK Investigational Site | Cottonwood | Arizona | 86326 | United States |
| GSK Investigational Site | Mesa | Arizona | 85206 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85006 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85014 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Tucson | Arizona | 85724 | United States |
| GSK Investigational Site | Fort Smith | Arkansas | 72901 | United States |
| GSK Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| GSK Investigational Site | Alamada | California | 94501 | United States |
| GSK Investigational Site | Bakersfield | California | 93301 | United States |
| GSK Investigational Site | Bakersfield | California | 93308 | United States |
| GSK Investigational Site | Beverly Hills | California | 90210 | United States |
| GSK Investigational Site | Carmichael | California | 95608 | United States |
| GSK Investigational Site | Fair Oaks | California | 95628 | United States |
| GSK Investigational Site | Fountain Valley | California | 92708 | United States |
| GSK Investigational Site | Loma Linda | California | 92354 | United States |
| GSK Investigational Site | Los Angeles | California | 90033 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Los Angeles | California | 90073 | United States |
| GSK Investigational Site | Los Angeles | California | 90211 | United States |
| GSK Investigational Site | Merced | California | 95348 | United States |
| GSK Investigational Site | Palm Springs | California | 92262 | United States |
| GSK Investigational Site | Poway | California | 92064 | United States |
| GSK Investigational Site | Redondo Beach | California | 90277 | United States |
| GSK Investigational Site | Sacramento | California | 95819 | United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | San Diego | California | 92161 | United States |
| GSK Investigational Site | Vista | California | 92081 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Aurora | Colorado | 80012 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| GSK Investigational Site | Littleton | Colorado | 80120 | United States |
| GSK Investigational Site | Bridgeport | Connecticut | 06606 | United States |
| GSK Investigational Site | Farmington | Connecticut | 06030 | United States |
| GSK Investigational Site | Guilford | Connecticut | 06437 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20017 | United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Bay Pines | Florida | 33744 | United States |
| GSK Investigational Site | Daytona Beach | Florida | 32114 | United States |
| GSK Investigational Site | Delray Beach | Florida | 33484 | United States |
| GSK Investigational Site | Fort Meyers | Florida | 33919 | United States |
| GSK Investigational Site | Gainesville | Florida | 32605 | United States |
| GSK Investigational Site | Hudson | Florida | 34667 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32207 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32216 | United States |
| GSK Investigational Site | Jupiter | Florida | 33458 | United States |
| GSK Investigational Site | Kissimmee | Florida | 34741 | United States |
| GSK Investigational Site | Largo | Florida | 33773 | United States |
| GSK Investigational Site | Melbourne | Florida | 32901 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Miami | Florida | 33137 | United States |
| GSK Investigational Site | Miami | Florida | 33176 | United States |
| GSK Investigational Site | Ocala | Florida | 34471 | United States |
| GSK Investigational Site | Orlando | Florida | 32803 | United States |
| GSK Investigational Site | Ormond Beach | Florida | 32174 | United States |
| GSK Investigational Site | Pensacola | Florida | 32514 | United States |
| GSK Investigational Site | Pinellas Park | Florida | 33781 | United States |
| GSK Investigational Site | Tampa | Florida | 33607 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30322 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30328 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Decatur | Georgia | 30030 | United States |
| GSK Investigational Site | Tucker | Georgia | 30084 | United States |
| GSK Investigational Site | Bannockburn | Illinois | 60015 | United States |
| GSK Investigational Site | Gurnee | Illinois | 60031 | United States |
| GSK Investigational Site | Normal | Illinois | 61761 | United States |
| GSK Investigational Site | Peoria | Illinois | 61603 | United States |
| GSK Investigational Site | Elkhart | Indiana | 46514 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | United States |
| GSK Investigational Site | La Porte | Indiana | 46350 | United States |
| GSK Investigational Site | South Bend | Indiana | 46601 | United States |
| GSK Investigational Site | Kansas City | Kansas | 66102 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40205 | United States |
| GSK Investigational Site | Mount Sterling | Kentucky | 40353 | United States |
| GSK Investigational Site | Covington | Louisiana | 70433 | United States |
| GSK Investigational Site | Lacombe | Louisiana | 70445 | United States |
| GSK Investigational Site | Auburn | Maine | 04210 | United States |
| GSK Investigational Site | Biddeford | Maine | 04005 | United States |
| GSK Investigational Site | Portland | Maine | 04106 | United States |
| GSK Investigational Site | Scarborough | Maine | 04074 | United States |
| GSK Investigational Site | Annapolis | Maryland | 20401 | United States |
| GSK Investigational Site | Ayer | Massachusetts | 01432 | United States |
| GSK Investigational Site | Brookline | Massachusetts | 02446 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 01655 | United States |
| GSK Investigational Site | Alpena | Michigan | 49707 | United States |
| GSK Investigational Site | Cadillac | Michigan | 49601 | United States |
| GSK Investigational Site | Detroit | Michigan | 48201 | United States |
| GSK Investigational Site | Kalamazoo | Michigan | 49048 | United States |
| GSK Investigational Site | Lansing | Michigan | 48910 | United States |
| GSK Investigational Site | Mineappolis | Minnesota | 55417 | United States |
| GSK Investigational Site | Rochester Hills | Minnesota | 48307 | United States |
| GSK Investigational Site | Saint Paul | Minnesota | 55102 | United States |
| GSK Investigational Site | Gulfport | Mississippi | 39503 | United States |
| GSK Investigational Site | Billings | Montana | 59101 | United States |
| GSK Investigational Site | Kalispell | Montana | 59901 | United States |
| GSK Investigational Site | Missoula | Montana | 59802 | United States |
| GSK Investigational Site | Morristown | New Jersey | 07962 | United States |
| GSK Investigational Site | Summit | New Jersey | 07901 | United States |
| GSK Investigational Site | Wayne | New Jersey | 07470 | United States |
| GSK Investigational Site | Babylon | New York | 11702 | United States |
| GSK Investigational Site | Buffalo | New York | 14209 | United States |
| GSK Investigational Site | Buffalo | New York | 14215 | United States |
| GSK Investigational Site | Mineola | New York | 11501 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | New York | New York | 10025 | United States |
| GSK Investigational Site | New York | New York | 10029 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | Troy | New York | 12180 | United States |
| GSK Investigational Site | West Islip | New York | 11794 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28080 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28203 | United States |
| GSK Investigational Site | Hickory | North Carolina | 28601 | United States |
| GSK Investigational Site | Statesville | North Carolina | 28625 | United States |
| GSK Investigational Site | Grand Forks | North Dakota | 58201 | United States |
| GSK Investigational Site | Akron | Ohio | 44304 | United States |
| GSK Investigational Site | Bryan | Ohio | 43506 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44106 | United States |
| GSK Investigational Site | Fairview Park | Ohio | 44126 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73109 | United States |
| GSK Investigational Site | Corvalis | Oregon | 97330 | United States |
| GSK Investigational Site | Hillsboro | Oregon | 97123-4117 | United States |
| GSK Investigational Site | Portland | Oregon | 97220 | United States |
| GSK Investigational Site | Portland | Oregon | 97223 | United States |
| GSK Investigational Site | Beaver | Pennsylvania | 15009 | United States |
| GSK Investigational Site | Greensburg | Pennsylvania | 15601 | United States |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| GSK Investigational Site | Langhorne | Pennsylvania | 19047 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| GSK Investigational Site | Ridley Park | Pennsylvania | 19078 | United States |
| GSK Investigational Site | West Chester | Pennsylvania | 19380 | United States |
| GSK Investigational Site | Wynnewood | Pennsylvania | 19096 | United States |
| GSK Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| GSK Investigational Site | Cranston | Rhode Island | 02920 | United States |
| GSK Investigational Site | Pawtucket | Rhode Island | 02860 | United States |
| GSK Investigational Site | Westerly | Rhode Island | 02891 | United States |
| GSK Investigational Site | Greer | South Carolina | 29651 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29302 | United States |
| GSK Investigational Site | Sioux Falls | South Dakota | 57105 | United States |
| GSK Investigational Site | Jackson | Tennessee | 38301 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38120 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Beaumont | Texas | 77702 | United States |
| GSK Investigational Site | Corpus Christi | Texas | 78404 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | Houston | Texas | 77074 | United States |
| GSK Investigational Site | Houston | Texas | 77090 | United States |
| GSK Investigational Site | Humble | Texas | 77338 | United States |
| GSK Investigational Site | Lubbock | Texas | 79410 | United States |
| GSK Investigational Site | McKinney | Texas | 75069 | United States |
| GSK Investigational Site | Odessa | Texas | 79761 | United States |
| GSK Investigational Site | Odessa | Texas | 79764 | United States |
| GSK Investigational Site | Orange | Texas | 77630 | United States |
| GSK Investigational Site | Tyler | Texas | 75701 | United States |
| GSK Investigational Site | Waco | Texas | 76712 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84124 | United States |
| GSK Investigational Site | Arlington | Virginia | 22204 | United States |
| GSK Investigational Site | Chesapeake | Virginia | 23510 | United States |
| GSK Investigational Site | Galax | Virginia | 24333 | United States |
| GSK Investigational Site | Richlands | Virginia | 24641 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Richmond | Virginia | 23294 | United States |
| GSK Investigational Site | Springfield | Virginia | 22151 | United States |
| GSK Investigational Site | Burien | Washington | 98166 | United States |
| GSK Investigational Site | Huntington | West Virginia | 25701 | United States |
| GSK Investigational Site | Beloit | Wisconsin | 53511 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53215 | United States |
| GSK Investigational Site | Wausau | Wisconsin | 54401 | United States |
| 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| OM8 Afib | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| OM8 Afib | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| OM8 Afib | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| OM8 Afib | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| OM8 Afib | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| OM8 Afib | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Paroxysmal AF, Placebo | Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. |
| FG002 | Persistent AF, P-OM3 | Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. |
| FG003 | Persistent AF, Placebo | Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paroxysmal AF, P-OM3 | Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record. |
| BG001 | Paroxysmal AF, Placebo | Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. |
| BG002 | Persistent AF, P-OM3 | Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. |
| BG003 | Persistent AF, Placebo | Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Modified Intent-to-Treat (MITT) Population: all randomized participants who provided at least one post-randomization TTM ECG data transfer or equivalent | Posted | Number | participants | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) |
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| Secondary | 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. | MITT Population | Posted | Number | participants | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population | Posted | Number | participants | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population | Posted | Number | participants | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population | Posted | Number | participants | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population | Posted | Number | participants | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population | Posted | Number | participants | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population | Posted | Number | participants | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis. | Posted | Number | participants | From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis. | Posted | Number | participants | From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis. | Posted | Number | participants | From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis. | Posted | Number | participants | From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population. The number analyzed represents those participants who had a rescue episode. | Posted | Median | Inter-Quartile Range | rescue episodes | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population. The number analyzed represents those participants with an event. | Posted | Median | Inter-Quartile Range | recurrences | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | MITT Population. The number analyzed represents those participants with an event. | Posted | Median | Inter-Quartile Range | recurrences | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) |
|
Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants receiving matching placebo | 20 | 331 | 66 | 331 | ||
| EG001 | Prescription Omega-3 Acid Ethyl Esters | Participants receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 | 25 | 332 | 82 | 332 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Cardiac discomfort | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Retroperitoneal hematoma | Gastrointestinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, version 12.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA, version 12.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA, version 12.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, version 12.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| False positive tuberculosis test | Investigations | MedDRA, version 12.1 | Systematic Assessment |
| |
| International normalized ratio increased | Investigations | MedDRA, version 12.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 12.1 | Systematic Assessment |
| |
| Gastrointestinal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 12.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA, version 12.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Suicide | Psychiatric disorders | MedDRA, version 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA, version 12.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA, version 12.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA, version 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA, version 12.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 12.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C405603 | Omacor |
Not provided
Not provided
Not provided
| Male |
|
| African American |
|
| Hispanic |
|
| American Indian |
|
| Asian |
|
| Unknown |
|
| OG003 | Combined, P-OM3 | Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
|
|
|
Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|
|
|
|
Participants with persistent AF receiving matching placebo
| OG003 | Persistent AF, P-OM3 | Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| OG003 |
| Persistent AF, P-OM3 |
Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
|
|
|
|
|
| OG003 | Persistent AF, P-OM3 | Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
|
|
|
| Participants |
|
|
|
| Persistent AF, P-OM3 |
Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
|
|
|
|
|
Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
| OG004 | Combined, Placebo | Participants with paroxysmal and persistent AF receiving matching placebo |
| OG005 | Combined, P-OM3 | Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
|
|
|
| OG004 | Combined, Placebo | Participants with paroxysmal and persistent AF receiving matching placebo |
| OG005 | Combined, P-OM3 | Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
|
|
|
| OG004 | Combined, Placebo | Participants with paroxysmal and persistent AF receiving matching placebo |
| OG005 | Combined, P-OM3 | Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24 |
|
|
|