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To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo (b.i.d.) |
|
| 2 | Experimental | Vernakalant (oral), 150 mg (b.i.d.) |
|
| 3 | Experimental | Vernakalant (oral), 300 mg (b.i.d.) |
|
| 4 | Experimental | Vernakalant (oral), 500 mg (b.i.d.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Vernakalant (oral) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first documented recurrence of symptomatic sustained AF. | Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing | |
| Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events | Safety assessments within Day 120 of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first documented recurrence of symptomatic or asymptomatic sustained AF | Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing | |
| Time to first documented recurrence of symptomatic AF | Time to first documented recurrence of symptomatic AF within 90 days of dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Beatch, PhD | Advanz Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | Australia | ||||
| Royal Hobart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21841207 | Derived | Torp-Pedersen C, Raev DH, Dickinson G, Butterfield NN, Mangal B, Beatch GN. A randomized, placebo-controlled study of vernakalant (oral) for the prevention of atrial fibrillation recurrence after cardioversion. Circ Arrhythm Electrophysiol. 2011 Oct;4(5):637-43. doi: 10.1161/CIRCEP.111.962340. Epub 2011 Aug 14. |
| Label | URL |
|---|---|
| Related Info | View source |
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Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.) |
|
|
| Time to first documented recurrence of symptomatic or asymptomatic AF | Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing |
| Proportion of subjects in sinus rhythm on Day 90. | Proportion of subjects in sinus rhythm on Day 90 of dosing |
| Improvement in AF symptoms as assessed by an AF symptom checklist. | Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing |
| Improvement in QOL as measured by SF-36 | Improvement in QOL as measured by SF-36 within Day 90 of dosing |
| Hobart |
| Australia |
| Launceston General Hospital | Launceston | Australia |
| Queen Elizabeth Hospital | Woodville | Australia |
| Princess Alexandra Hospital | Woolloongabba | Australia |
| A. Z. Middelheim | Antwerp | Belgium |
| Imelda Ziekenhuis | Bonheiden | Belgium |
| U. Z. Gasthuisberg | Leuven | Belgium |
| Heilig Hart Ziekenhuis | Roeselare | Belgium |
| MHAT - Haskovo | Haskovo | Bulgaria |
| UMHAT 'Dr. Georgi Stranski' | Pleven | Bulgaria |
| MHAT 'Rouse AD' | Rousse | Bulgaria |
| IV MHAT | Sofia | Bulgaria |
| MHAT 'Tzaritza Yoanna' | Sofia | Bulgaria |
| MI Central Clinical Base - Ministry of Interior | Sofia | Bulgaria |
| Military Medical Academy | Sofia | Bulgaria |
| MHAT 'Sveta Marina' | Varna | Bulgaria |
| MMA - Hospital Base for Active Treatment - Varna | Varna | Bulgaria |
| General Hospital Zadar | Zadar | Croatia |
| Clinical Hospital Dubrava | Zagreb | Croatia |
| General Hospital Sveti Duh | Zagreb | Croatia |
| University Hospital " Merkur " | Zagreb | Croatia |
| Nemocnice Jindrichuv Hradec, a.s. | Jindřichův Hradec | Czechia |
| Kromerizska Nemocnice, a.s. | Kroměříž | Czechia |
| Nemocnice Kutna Hora s.r.o. | Kutná Hora | Czechia |
| Fakultni Nemocnice Plzen | Pilsen | Czechia |
| Vojenska Nemocnice Praha | Prague | Czechia |
| Vseobecna Fakultni Nemocnice v Praze | Prague | Czechia |
| Oblastni Nemocnice Pribram, a.s. | Příbram | Czechia |
| Nemocnice v Semilech | Semily | Czechia |
| Nemocnice Slany | Slaný | Czechia |
| Nemocnice Tabor, a.s. | Tábor | Czechia |
| Nemocnice Trebic, p.o. | Třebíč | Czechia |
| Bispebjerg Hospital | Copenhagen | Denmark |
| Frederiksberg Hospital | Frederiksberg | Denmark |
| Gentofte Amtssygehus | Hellerup | Denmark |
| Sygehus Vendsyssel - Hjørring | Hjørring | Denmark |
| Kolding Sygehus | Kolding | Denmark |
| Region Sjælland Sygehus øst Køge | Køge | Denmark |
| Viimsi Hospital | Haabneeme | Estonia |
| Pärnu Hospital | Pärnu | Estonia |
| North Estonia Regional Hospital | Tallinn | Estonia |
| Tartu University Hospital | Tartu | Estonia |
| Herzzentrum Bad Krozingen | Bad Krozingen | Germany |
| Kerckhoff-Klinik Forschungsgesellschaft mbH | Bad Nauheim | Germany |
| Evangelisches Krankenhaus | Witten | Germany |
| Magyar Imre Hospital | Ajka | Hungary |
| Baja City Community Hospital | Baja | Hungary |
| Nyiro Gyula Hospital | Budapest | Hungary |
| Péterfy Sándor Hospital | Budapest | Hungary |
| Szent Istvan Hospital | Budapest | Hungary |
| Bugat Pal Hospital | Gyöngyös | Hungary |
| Petz Aladár County Teaching Hospital | Győr | Hungary |
| Bacs-Kiskun County Hospital | Kecskemét | Hungary |
| Fejér Megyei Szent György Kórház | Székesfehérvár | Hungary |
| Hetenyi Geza County Hospital | Szolnok | Hungary |
| Zala County Hospital | Zalaegerszeg | Hungary |
| Kaunas Medical University Hospital | Kaunas | Lithuania |
| Klaipeda Seamen's Hospital | Klaipėda | Lithuania |
| Vilnius University Hospital Santariskiu Clinic | Vilnius | Lithuania |
| VU Medisch Centrum | Amsterdam | Netherlands |
| Reinier de Graaf Groep | Delft | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Martini Ziekenhuis | Groningen | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | Netherlands |
| Stichting Sint Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Isala Klinieken | Zwolle | Netherlands |
| North Shore Hospital | Auckland | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Waikato Hospital | Hamilton | New Zealand |
| Nelson Hospital | Nelson | New Zealand |
| SZZOZ Wielospecjalityczny Szpital Miejski im. Dr. E.Warminsk | Bydgoszcz | Poland |
| Szpital Powiatowy | Chrzanów | Poland |
| Instytut Kardiologii AMG | Gdansk | Poland |
| Szpital Miejski w Gdyni | Gdynia | Poland |
| Zaklad Farmakologii i Terapii Monitorowanej z Oddzialem Chor | Lodz | Poland |
| SP ZOZ Okregowy Szpital Kolejowy | Lublin | Poland |
| Szpital Wojewodzki Nr 2 | Rzeszów | Poland |
| Klinika Kardiologii PAM | Szczecin | Poland |
| Szpital Specjalistyczny | Tarnów | Poland |
| III Klinika Chorob Wewnetrznych i Kardiologii | Warsaw | Poland |
| Wojskowy Instytut Medyczny, CSK MON | Warsaw | Poland |
| Osrodek Chorob Serca, 4Wojskowy Szpital Kliniczny z Poliklin | Wroclaw | Poland |
| Hospital Fernando da Fonseca | Amadora | Portugal |
| Hospital de Santa Marta | Lisbon | Portugal |
| Centro Hospitalar Vila Nova de Gaia | Vila Nova de Gaia | Portugal |
| Spitalul Clinic Judetean de Urgenta Arad | Arad | Romania |
| Spitalul Clinic Judetean de Urgenta Brasov | Brasov | Romania |
| Institutul de Cardiologie C.C. Iliescu | Bucharest | Romania |
| Spitalul Clinic Colentina | Bucharest | Romania |
| Spitalul Clinic de Urgenta Sf. Pantelimon | Bucharest | Romania |
| Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi | Lasi | Romania |
| Spitalul Clinic Judetean Oradea | Oradea | Romania |
| Spitalul Judetean de Urgenta Ploiesti | Ploieşti | Romania |
| Spitalul Clinic Judetean de Urgenta Targu Mures | Târgu Mureş | Romania |
| Spitalul Clinic Municipal de Urgenta Timisoara | Timișoara | Romania |
| FSI EMC of the President of RF, b.o. City Hospital #51 | Moscow | Russia |
| MedCentre of RF President, Central Clinical Hospital | Moscow | Russia |
| Moscow City Hospital # 29 | Moscow | Russia |
| Moscow Medical Academy. City Hospital #20 | Moscow | Russia |
| Moscow SHI City Clinical Hospital #52 | Moscow | Russia |
| RMA of Postg. education b.o. Botkin City Clinical Hospital | Moscow | Russia |
| Russian Cardiology Research Centre | Moscow | Russia |
| War Veteran's Hospital #3 | Moscow | Russia |
| Pokrovskaya City Hospital | Saint Petersburg | Russia |
| St- Petersburg GUZ City Hospital #15 | Saint Petersburg | Russia |
| Yaroslavl Regional Clinical Hospital | Yaroslavl | Russia |
| Yaroslavl State Medical Academy b.o. Clinical Hospital #2 | Yaroslavl | Russia |
| Clinical Center of Serbia | Belgrade | Serbia |
| Dedinje Cardiovascular Institute | Belgrade | Serbia |
| Institute of CV Diseases, Clinical Center of Serbia | Belgrade | Serbia |
| Institute of Cardiovascular Diseases Sremska Kamenica | Kamenitz | Serbia |
| Clinical Center for Cardiovascular Diseases | Niška Banja | Serbia |
| Clinical Center Bezanijska Kosa | Zemun | Serbia |
| Clinical Center Zemun | Zemun | Serbia |
| National Heart Center | Singapore | Singapore |
| FNsP Bratislava - Pracovisko Stare Mesto | Bratislava | Slovakia |
| Slovensky Ustav Srdcovocievnych Chorob | Bratislava | Slovakia |
| Vychodoslovensky Ustav Srdcovocievnych Chorob | Košice | Slovakia |
| Fakultna Nemocnica Nitra | Nitra | Slovakia |
| FNsP Nove Zamky | Nové Zámky | Slovakia |
| FNsP J. A. Reimana | Prešov | Slovakia |
| Clinresco Centres (Pty) Ltd | Kempton Park | South Africa |
| Vergelegen Medi-Clinic | Somerset West | South Africa |
| Clinical Project Research | Worcester | South Africa |
| Hospital Vall D'Hebron | Barcelona | Spain |
| Hosp. Virgen de las Nieves | Granada | Spain |
| Clinica Universitaria Puerta de Hierro | Madrid | Spain |
| Hosp. Clinico San Carlos | Madrid | Spain |
| Hospital Ramon y Cajal | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Univ. Tarragona Joan XXIII | Tarragona | Spain |
| Universitetssjukhuset Malmö | Malmö | Sweden |
| Universitetssjukhuset Örebro | Örebro | Sweden |
| Akademiska Sjukhuset | Uppsala | Sweden |
| Universitaetsspital Basel | Basel | Switzerland |
| Kantonsspital Liestal | Liestal | Switzerland |
| Cardio Centro Ticino | Lugano | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | Switzerland |
| Reg.Diag.Center of Dnepr. | Dnipro | Ukraine |
| Cent.City Clin.Hosp.#3.Chair of Int.Dis.#2 of Donetsk SMU | Donetsk | Ukraine |
| Donetsk Regional Clinical Hospital | Donetsk | Ukraine |
| City Clinical Hospital #8 | Kharkiv | Ukraine |
| City Clinical Hospital #1 | Kiev | Ukraine |
| Kiev City Clinical Hospital No 5, Coronary Care Unit | Kiev | Ukraine |
| Kiev Clinical Emergency Care Hospital | Kiev | Ukraine |
| M.D.Strazhesko Institut of Cardiology | Kiev | Ukraine |
| N.D. Strazhesko Institute of Cardiology | Kiev | Ukraine |
| Lugansk First Clinical Multiprofile Hospital #1, cardiology | Luhansk | Ukraine |
| Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre | Lviv | Ukraine |
| City Clinical Hospital #9 | Odesa | Ukraine |
| Hospital Therapy Dept #1of Zaporozhye SMU | Zaporizhzhya | Ukraine |
| 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 |
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| ID | Term |
|---|---|
| C524581 | vernakalant |
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