Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study
NCT ID: NCT00526136
Last Updated: 2008-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
735 participants
INTERVENTIONAL
2007-03-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Placebo (b.i.d.)
Placebo
2
Vernakalant (oral), 150 mg (b.i.d.)
Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
3
Vernakalant (oral), 300 mg (b.i.d.)
Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
4
Vernakalant (oral), 500 mg (b.i.d.)
Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Interventions
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Placebo
Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be 18 to 85 years of age
* Women must not be pregnant, be non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 3 months after the last dose of medication. Methods of birth control considered to be effective may include hormonal contraception (the pill), an intrauterine device (IUD), condoms in combination with a spermicidal cream, total abstinence or sterilisation. Men should be advised not to conceive a child and are advised to use an effective form of birth control from admission until 3 months after the last dose of study medication
* Have symptomatic AF that has been sustained for greater than 72 hours and less than 6 months duration and is clinically indicated for cardioversion;
* Have adequate anticoagulant therapy for cardioversion in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines (Fuster V. et al, 2006);
* Be haemodynamically stable (100 mmHg \< systolic blood pressure \< 190 mmHg) at screening and on Day 1 before dosing (while taking rate control drugs, if required). After resting supine for 3 minutes, blood pressures should be measured 3 times in 5 minutes with at least 1 minute between assessments;
* Have a body weight between 45 and 113 kg (99 and 250 lbs).
Exclusion Criteria
* Have a QRS \>0.140 sec;
* Documented previous episodes of second or third-degree atrioventricular block;
* Have clinically significant persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker;
* Have clinically significant moderate or severe aortic valvular stenosis (gradient \>25 mmHg), hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;
* Have Class III or Class IV congestive heart failure at screening or admission, or have been hospitalized for heart failure in the previous 6 months;
* Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study; h) Have serious pulmonary, hepatic, metabolic, renal (serum creatinine \> 2.0 mg/dl), gastrointestinal, central nervous system (CNS) or psychiatric disease, end-stage disease states, or any other disease that could interfere with the conduct or validity of the study or compromise subject safety;
* Have known concurrent temporary secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation \< 90% on room air), acute pericarditis, or myocarditis;
* Potassium (K+) \<3.5 mmol/L or \>5.5 mmol/L or magnesium (Mg2+) below the lower limit of normal (Mg2+\< 0.65 mmol/L in subjects 65 years or younger and \<0.80 mmol/L in subjects 66 years or older). (Both K+ and Mg2+ should be corrected prior to dosing);
* Have clinical evidence of digoxin toxicity;
* Have received an oral Class I or Class III antiarrhythmic agent (including sotalol) within 3 days of randomisation or oral amiodarone within 4 weeks, or have received intravenous Class I or Class III antiarrhythmic agent or i.v. amiodarone within 24 hours prior to start of dosing;
* Have any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons;
* Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to screening;
* Be unable to communicate well with the Investigator and to comply with the requirements of the entire study;
18 Years
85 Years
ALL
No
Sponsors
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Advanz Pharma
INDUSTRY
Responsible Party
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Cardiome Pharma Corp.
Principal Investigators
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Gregory Beatch, PhD
Role: STUDY_DIRECTOR
Advanz Pharma
Locations
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Royal Adelaide Hospital
Adelaide, , Australia
Royal Hobart Hospital
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
Malmo, , 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
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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1235-SR-202-AF
Identifier Type: -
Identifier Source: org_study_id