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| Sponsor: | Cardiome Pharma |
|---|---|
| Information provided by: | Cardiome Pharma |
| ClinicalTrials.gov Identifier: | NCT00668759 |
Purpose
The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: Vernakalant Injection Drug: Amiodarone Injection: |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation |
| Estimated Enrollment: | 240 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Vernakalant Injection: In one infusion line, subjects will receive a 10-minute infusion of vernakalant followed by a 15-minute observation period, followed by an additional 10-minute infusion of vernakalant if required (if the subject is still in AF). To maintain blinding, a 60-minute infusion of placebo (D5W) will be administered in a second infusion line, followed by a maintenance infusion of placebo for a minimum of an additional 60 minutes. |
Drug: Vernakalant Injection
10-minute infusion of 3 mg/kg vernakalant injection followed by a 15-minute observation period, followed by an additional 10-minute infusion of 2 mg/kg of vernakalant if required (if the subject is still in AF).
|
|
2: Active Comparator
Amiodarone Injection: In one infusion line subjects will receive a 60-minute infusion of amiodarone followed by a maintenance infusion of amiodarone over an additional 60 minutes. To maintain blinding, a 10-minute infusion of placebo (normal saline) will be administered in a second infusion line, followed by a 15 minute observation period, followed by a 10 minute infusion of placebo if the subject is still in AF. |
Drug: Amiodarone Injection:
60-minute infusion of 5 mg/kg amiodarone followed by a maintenance infusion of 50 mg amiodarone over an additional 60 minutes (equivalent to approximately 15 mg/kg over 24 hrs).
|
This is a double-blind, active-controlled, double-dummy, multi-center, randomized trial in subjects with symptomatic AF of 3 to 48 hours duration.
Subjects will be randomized to receive vernakalant injection or amiodarone injection in a 1:1 ratio.
Safety will be assessed through the monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.
At 2 hours after the start of infusion, electrical cardioversion may be performed or rate control medication may be administered. Class I and Class III antiarrhythmics are not to be administered for 24 hours after the start of infusion.
Subjects are to remain in the clinic for at least 6 hours after the start of infusion. Subjects will attend a follow-up visit at 7 (±2) days after treatment and will receive a follow-up telephone call at 30 (±3) days for assessment of serious adverse events, concomitant medications related to serious adverse events, and recurrence of AF.
All roles were blinded with the exception of each site's designated unblinded personnel who were responsible for randomization and preparation, dispensation and accountability of the study medication.
Expanded Access was not available through this protocol.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contacts and Locations| Contact: Heather Kato, MAppSc | 604-677-6905 ext 135 | hkato@cardiome.com |
| Contact: Paul Holzapfel, RN, BSN | 604-677-6905 ext 320 | pholzapfel@cardiome.com |
Hide Study Locations| Australia, South Australia | |
| Royal Adelaide Hospital | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Ashley Roach 61 08 82222889 ashley.roach@health.sa.gov.au | |
| Principal Investigator: Julie Bradley, MD | |
| Australia, Tasmania | |
| Royal Hobart Hospital Cardiology Research | Recruiting |
| Hobart, Tasmania, Australia, 7000 | |
| Contact: Cathy McIntosh 61 3 6222 8287 cathy.mcintosh@dhhs.tas.gov.au | |
| Principal Investigator: Phil Roberts-Thomson, MD | |
| Launceston General Hospital Cardiac Research Unit | Recruiting |
| Launceston, Tasmania, Australia | |
| Contact: Gail McBain 61 3 63487583 gail.mcbain@dhhs.tas.gov.au | |
| Principal Investigator: Bhuwan Singh, MD | |
| Australia, Western Australia | |
| Royal Perth Hospital Emergency Research | Recruiting |
| Perth, Western Australia, Australia, 6000 | |
| Contact: Ellen MacDonald 61 8 9224 1724 ellen.macdonald@heath.wa.gov.au | |
| Principal Investigator: Simon Brown, MD | |
| Canada, Ontario | |
| Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Kathryn Bowes 613 549 6666 ext 2738 Bowesk@kgh.kari.net | |
| Principal Investigator: Marco Sivilotti, MD | |
| The Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Contact: Cathy Clement, RN 613 798 5555 ext 16615 cclement@ohri.ca | |
| Principal Investigator: Ian Stiell, MD | |
| Canada, Quebec | |
| Hopital de la Cite-de-la-Sante | Recruiting |
| Laval, Quebec, Canada, H7M 3L9 | |
| Contact: Eric Daviau 450-668-1010 ext 2132 recherché.cardiologie.csssl@ssss.gouv.qc.ca | |
| Principal Investigator: Mayrand Helene, MD | |
| Institut de Cardiologie de Montreal | Recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Contact: Constance Bossy, RN 514 376 3330 ext 2884 Constance.Bossy@icm-mhi.org | |
| Principal Investigator: Denis Roy, MD | |
| Centre Hopitalier de L'Universite de Montreal - Hotel Dieu | Recruiting |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Contact: Carole Lemay, RN 514 890 8000 ext 14803 recherche.cardio.hd.chum@ssss.gouv.gc.ca | |
| Principal Investigator: Paolo Costi, MD | |
| McGill University Health Center The Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Contact: Caroline Boudreault 514 934 1934 ext 43038 caroline.boudreault@muhc.mcgill.ca | |
| Principal Investigator: Thao Huynh, MD | |
| Centre de santé et de services sociaux du Sud de Lanaudière - Hôpital Pierre-Le Gardeur | Recruiting |
| Terrebonne, Quebec, Canada, J6V 2H2 | |
| Contact: Margaux David, RN 450 654 7525 ext 11104 chlg.rech.cardio@ssss.gouv.qc.ca | |
| Principal Investigator: Denis-Carl Phaneuf, MD | |
| Czech Republic | |
| Mestrska nemocnice Caslav | Recruiting |
| Caslav, Czech Republic, 286 01 | |
| Contact: Hana Grunfeldova, MD 420 327 305 152 grunfeldova@email.cz | |
| Principal Investigator: Hana Grunfeldova, MD | |
| Nemocnice Kroměříž | Terminated |
| Kroměříž, Czech Republic, 767 55 | |
| Nemocnice Kutna Hora s.r.o. Interni Oddeleni | Terminated |
| Kutna Hora, Czech Republic | |
| Nemocnice Decin Internal Medicine | Recruiting |
| Nove Město, Czech Republic, 405 02 | |
| Contact: Michal Hondl, MD 420 737 889 772 michal.hondl@nemdc.cz | |
| Principal Investigator: Michal Hondl, MD | |
| VFN - III. Interni Klinika | Recruiting |
| Praha, Czech Republic | |
| Contact: Tomas Janota, MD 420-224-962-934 | |
| Principal Investigator: Tomas Janota, MD | |
| Oblastni nemocnice Pribram Interni Oddeleni | Terminated |
| Pribram, Czech Republic | |
| Fakultní nemocnice v Motole, KAR | Terminated |
| Praha, Czech Republic, 150 00 | |
| Ustredni vojenska nemocnice Koronarni jednotka | Terminated |
| Praha, Czech Republic, 162 00 | |
| Nemocnice v Semilech Interní oddělení | Recruiting |
| Semily, Czech Republic | |
| Contact: Pavel Sabl, MD 420-481-661-333 | |
| Principal Investigator: Pavel Sabl, MD | |
| Nemocnice Slaný Interní oddělení | Recruiting |
| Slaný, Czech Republic | |
| Contact: Ondrej Cermak, MD 420-312-575-338 | |
| Principal Investigator: Ondrej Cermak, MD | |
| Nemocnice Tabor | Recruiting |
| Tabor, Czech Republic, 390 03 | |
| Contact: Jana Mikulova, MD 420 602 692 259 janamikulova@seznam.cz | |
| Principal Investigator: Jana Mikulova, MD | |
| Uherskohradistska nemocnice | Recruiting |
| Uherské Hradiste, Czech Republic, 686 08 | |
| Contact: Stanislav Zemek, MD 420 724 631 007 zemeks@post.cz | |
| Principal Investigator: Stanislav Zemek, MD | |
| Denmark | |
| Gentofte Amtssygehus Kardiologisk afdeling | Recruiting |
| Hellerup, Denmark | |
| Contact: Gitte von Jessen 45 35 31 27 71 gvj@heart.dk | |
| Principal Investigator: Christian Torp-Pedersen, MD | |
| Herlev Amtssygehus, Kardiologisk | Terminated |
| Herlev, Denmark, 2730 | |
| Sygehus Vendsyssel Hjorring | Recruiting |
| Hjorring, Denmark | |
| Contact: Jens Petersen, MD 45 99 64 31 01 | |
| Principal Investigator: Jens Petersen, MD | |
| Roskilde Amts Sygehus Køge | Recruiting |
| Koge, Denmark | |
| Contact: Lone Brinksby 45 47 32 25 56 | |
| Principal Investigator: Kim Klarlund, MD | |
| Regionshospitalet Silkeborg | Recruiting |
| Silkeborg, Denmark | |
| Contact: Malene Mortensen 45 87 22 23 49 projektM1@sc.aaa.dk | |
| Principal Investigator: Lars Frost, MD | |
| Estonia | |
| Viimsi Hospital, Heart Clinic | Recruiting |
| Haabneeme, Estonia, 74001 | |
| Contact: Juri Kaik, MD 372 5 031931 Jyri.Kaik@mail.ee | |
| Principal Investigator: Juri Kaik, MD | |
| Pärnu Hospital Department of Cardiology | Recruiting |
| Parnu, Estonia | |
| Contact: Veiko Vahula, MD 372 44 73310 | |
| Principal Investigator: Veiko Vahula, MD | |
| East Tallinn Central Hospital-Clinic of Cardiology | Recruiting |
| Tallinn, Estonia | |
| Contact: Anne Kork, MD 372 62 07056 | |
| Principal Investigator: Anne Kork, MD | |
| Tartu University Hospital Heart Clinic | Active, not recruiting |
| Tartu, Estonia | |
| Finland | |
| Oulu University Hospital - Dept of Internal Medicine | Active, not recruiting |
| Oulu, Finland, 90014 | |
| France | |
| Hopital Trousseau - Service de Cardiologie | Recruiting |
| Chambray-les-Tours, France | |
| Contact: Dominique Babuty, MD 33 0 247 47 46 50 | |
| Principal Investigator: Dominique Babuty, MD | |
| CHU de Nancy - Hopital Brabois - Service de Cardiologie | Recruiting |
| Nancy, France | |
| Contact: Etienne Aliot, MD 33 3 83 15 32 96 | |
| Principal Investigator: Etienne Aliot, MD | |
| Hôpital Lariboisiere | Terminated |
| Paris, France | |
| CHU de Strasbourg - Hopital Hautepierre - Service de Cardiologie | Terminated |
| Strasbourg, France | |
| Germany | |
| Campus Virchow-Klinikum, Charite - Universitaetsmedizin Berlin | Recruiting |
| Berlin, Germany | |
| Contact: Wilhelm Haverkamp, MD 49 30 450 653366 | |
| Principal Investigator: Wilhelm Haverkamp, MD | |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Recruiting |
| Ludwigshafen, Germany, 67063 | |
| Contact: Petra Zaricor 49 621 503 4354 zaricorp@klilu.de | |
| Principal Investigator: Karlheinz Seidl, MD | |
| Herzzentrum Brandenburg in Bernau Innere Medizin | Recruiting |
| Bernau, Germany, 16321 | |
| Contact: Christian Butter, MD 49 3 338 694 610 c.butter@immanuel.de | |
| Principal Investigator: Christian Butter, MD | |
| Universitätsklinikum Bonn, Med. Klinik und Poliklinik II | Terminated |
| Bonn, Germany, 53105 | |
| Johann Wolfgang Goethe Universitaet Med Klinik III - Kardiologie | Recruiting |
| Frankfurt, Germany | |
| Contact: Stefan Hohnloser, MD 49 69 6301 7404 | |
| Principal Investigator: Stefan Hohnloser, MD | |
| Universitatsklinikum Gottingen, Herzzentrum | Recruiting |
| Gottingen, Germany, 37075 | |
| Contact: Rolf Wachter, MD 49 551 398920 | |
| Principal Investigator: Rolf Wachter, MD | |
| Martin-Luther Universitat Halle, Med. Klinik und Poliklinik III- Fachrichtung Kardiologie | Recruiting |
| Halle, Germany | |
| Contact: Michael Buerke, MD 49 221 4783 2401 | |
| Principal Investigator: Michael Buerke, MD | |
| Klinik Hamburg Bambek Kardiologie | Recruiting |
| Hamburg, Germany, 22291 | |
| Contact: Thora Botschafter 49 40 18 18 82 6317 t.botschafter@asklepios.com | |
| Principal Investigator: Gerian Grönefeld, MD | |
| Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH | Recruiting |
| Hamburg, Germany, 22527 | |
| Contact: Dr. Tuebler, MD 49 40 889 009 899 | |
| Contact: Frau Hoffmann 49 40 889 009 899 hoffmann@herz-hh.de | |
| Principal Investigator: Carsten Schwencke, MD | |
| Medizinische Klinik, Klinikum Hannover Nordstadt | Recruiting |
| Hannover, Germany | |
| Contact: Johannes Hensen, MD 49 511 9701291 | |
| Principal Investigator: Johannes Hensen, MD | |
| Ambulantes Herzzentrum Kassel Innere Medizin | Recruiting |
| Kassel, Germany, 34121 | |
| Contact: Ines Pietsch 49 (0)561 93769150 | |
| Contact: Petra Becker 49 (0)561 93769150 | |
| Principal Investigator: Andreas Utech, MD | |
| Klinikum der Universität Köln, Medizinische Klinik III | Terminated |
| Köln, Germany, 50924 | |
| Charite Campus Mitte, Med. Klinik und Poliklinik mit Schwerpunkt Kardiologie und Angiologie | Terminated |
| Berlin, Germany, 10117 | |
| Carl-von Basedow-Klinikum Merseburg | Recruiting |
| Merseburg, Germany, 06217 | |
| Contact: Frau Dr. Susanne Rode, MD S.Burghard@klinikum-saalekreis.de | |
| Principal Investigator: Roland Prondzinsky, MD | |
| Klinikum Pirna GmbH, Innere Medizin II, Kardiologie | Recruiting |
| Pirna, Germany | |
| Contact: Christoph Axthelm, MD 49 3501 7118 5041 | |
| Principal Investigator: Christoph Axthelm, MD | |
| Krankenhaus Reinbek, St. Adolf-Stift | Recruiting |
| Reinbek, Germany | |
| Contact: Herbert Naegele, MD 49 40 72805158 | |
| Principal Investigator: Herbert Naegele, MD | |
| Robert-Bosch-Krankenhaus, Abt. Kardiologie / Pulmologie | Terminated |
| Stuttgart, Germany, 70376 | |
| Latvia | |
| Latvian Center of Cardiology, P. Stradins Clinical University Hospital | Recruiting |
| Riga, Latvia, LV1002 | |
| Contact: Iveta Mintale 371 67069959 iveta.mintale@stradini.lv | |
| Principal Investigator: Andrejs Erglis, MD | |
| Lithuania | |
| Kaunas Medical University Hospital - Department of Cardiology | Active, not recruiting |
| Kaunas, Lithuania | |
| Klaipeda Seamen's Hospital | Active, not recruiting |
| Klaipeda, Lithuania | |
| Vilnius University Hospital Santariskiu Clinic - Center of Cardiology and Angiology | Active, not recruiting |
| Vilnius, Lithuania | |
| Netherlands | |
| WCN - Department of Cardiology Rijnstate Ziekenhuls | Recruiting |
| Arnhem, Netherlands, 6-800 TA | |
| Contact: F F Willems, MD 31 88 005 7543 f.willem7@chello.nl | |
| Principal Investigator: F F Willems, MD | |
| Catharina Ziekenhuis Eindhoven | Recruiting |
| Eindhoven, Netherlands, 5623EJ | |
| Contact: Antoinette Spierings 31 40 2398362 carapl@cze.nl | |
| Principal Investigator: H R Michels, MD | |
| Groene Hart Zeikenhhaus | Recruiting |
| Gouda, Netherlands, 2800BB | |
| Contact: Marijke de Wit 31 18 250 5360 marijke.de.wit@ghz.nl | |
| Contact: Mrs. Kramer 31 18 250 5360 hanneke.kramer@ghz.nl | |
| Principal Investigator: Eric Viergever, MD | |
| WCN - Bethesda ziekenhuis | Recruiting |
| Hoogeveen, Netherlands, 7909 AA | |
| Contact: S H K The, MD 31 052 828 6222 shkthe@bethesda.nl | |
| Principal Investigator: S H K The, MD | |
| Academisch Ziekenhuis Maastricht | Recruiting |
| Maastricht, Netherlands, 6229 HX | |
| Contact: Iris Partouns-Hendricks 31 43 387 7091 iris.partouns.hendricks@mumc.nl | |
| Principal Investigator: An Moens, MD | |
| WCN - Canisius-Wilhelmina Ziekenhuis | Recruiting |
| Nijmegen, Netherlands, 6532 SZ | |
| Contact: Astrid Schut 31 24 365 8789 Res.car@cwz.nl | |
| Principal Investigator: D P Hertzberger, MD | |
| WCN - St. Franciscus Gasthuis | Recruiting |
| Rotterdam, Netherlands, 3045 PM | |
| Contact: Irene Kort 31 10 461 6790 i.kort@sfg.nl | |
| Contact: Ingrid Danse 31 10 461 6790 i.danse@sfg.nl | |
| Principal Investigator: P R Nierop, MD | |
| Poland | |
| Oddzial Kardiologiczny Wielospecjalityczny Szpital Miejski im. | Recruiting |
| Bydgoszcz, Poland | |
| Contact: Andrzej Hoffmann, MD 48 52 3709300 | |
| Principal Investigator: Andrzej Hoffmann, MD | |
| Szpital Miejski im. J. Brudzinskiego Oddzial Kardiologii | Recruiting |
| Gdynia, Poland | |
| Contact: Pawel Miekus, MD 48 58 6665580 | |
| Principal Investigator: Pawel Miekus, MD | |
| Klinika Chorob Wewnetrznych z Oddzialem Farmakologii Klinicznej i Terapii Monitorowanej | Recruiting |
| Lodz, Poland | |
| Contact: Marlena Broncel, MD 48 42 2516002 | |
| Principal Investigator: Marlena Broncel, MD | |
| Okregowy Szpital Kolejowy w Lublinie Samodzielny | Active, not recruiting |
| Lublin, Poland | |
| III Klinika Chorob Wewnetrznych i Kardiologii | Recruiting |
| Warszawa, Poland, 00-382 | |
| Contact: Krzysztof Makowiecki, MD 48 22 6252231 | |
| Principal Investigator: Krzysztof Makowiecki, MD | |
| Oddzial Kardiologii Inwazyjnej Szpital Specjalistyczny im. E.Szczeklika w Tarnowie | Terminated |
| Tarnow, Poland, 33-100 | |
| Oddział Kardiologiczno-Internistyczny Specjalistyczny Szpital Miejski im. Mikołaja Kopernika | Recruiting |
| Toruń, Poland, 87-100 | |
| Contact: Bartłomiej Jończy, MD 48 56 610 02 50 bartjon@o2.pl | |
| Principal Investigator: Bartłomiej Jończy, MD | |
| Specjalistyczny Szpital Miejski im. Mikołaja Kopernika | Recruiting |
| Toruń, Poland, 87-100 | |
| Contact: Lidia Pawlowicz, MD 48 56 610 02 45 lpawlowicz@ksiaznica.torun.pl | |
| Principal Investigator: Lidia Pawlowicz, MD | |
| Wojskowy Instytut Medyczny, CSK MON | Recruiting |
| Warszawa, Poland, 00-909 | |
| Contact: Leszek Kubik, MD 48 22 6816585 | |
| Principal Investigator: Leszek Kubik, MD | |
| Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Szpital Wojewódzki im. Jana Bożego w Lublinie | Recruiting |
| Lublin, Poland, 20-089 | |
| Contact: Hanna Lewandowska, MD 48 81 740 26 75 hannals@o2.pl | |
| Principal Investigator: Hanna Lewandowska, MD | |
| Klinika Kardiologii Zachowawczej Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie | Recruiting |
| Warszawa, Poland, 02-507 | |
| Contact: Marek Kochmański 48 22 508 16 70 | |
| Principal Investigator: Marek Kochmański, MD | |
| Osrodek Chorob Serca, Klinika Kardiologii, 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny | Recruiting |
| Wroclaw, Poland | |
| Contact: Piotr Ponikowski, MD 48 71 7660250 | |
| Principal Investigator: Piotr Ponikowski, MD | |
| Serbia | |
| "Dedinje" Cardiovascular Institute | Recruiting |
| Belgrade, Serbia, 11040 | |
| Contact: Petar Otasevic 381 11 360 16 69 potasevic@yahoo.com | |
| Principal Investigator: Milorad Borzanovic, MD | |
| Clinical Center of Serbia, Institute of CV Diseases | Recruiting |
| Belgrade, Serbia, 11000 | |
| Contact: Arsen Ristic 381 11 361 47 38 | |
| Principal Investigator: Petar Seferovic, MD | |
| Institute of Treatment and Reahabilitation 'Niska Banja' | Recruiting |
| Niska Banja, Serbia, 18205 | |
| Contact: Bojan Ilic 381 18 450 22 26 bojanil@eunet.rs | |
| Principal Investigator: Stevan Ilic, MD | |
| Clinical Center Zemun, Dept. of Cardiology | Recruiting |
| Zemun, Serbia, 11080 | |
| Contact: Predrag Milicevic +381 11 377 27 62 milicevicp@hotmail.com | |
| Principal Investigator: Putnikovic Biljana, MD | |
| Slovakia | |
| Middle Slovak Institute of Cardiovascular Diseases (SUSCCH) | Recruiting |
| Banska Bysterica, Slovakia, 97401 | |
| Contact: Gabriela Kaliska, MD 421 48 441 3059 | |
| Principal Investigator: Gabriela Kaliska, MD | |
| Interna klinika FN Trnava, Fakultna nemocnica Trnava | Recruiting |
| Trnava, Slovakia, 91701 | |
| Contact: Vladimir Macek, MD 421 33 593 8251 | |
| Principal Investigator: Vladimir Macek, MD | |
| Slovensky ustav srdcovych a cevnych chorob | Terminated |
| Bratislava, Slovakia, 83348 | |
| ICU, Hospital Lipt. Mikulas | Recruiting |
| Liptovsky Mikulas, Slovakia, 03101 | |
| Contact: Peter - Kycina, MD | |
| Principal Investigator: Peter - Kycina, MD | |
| FN - I. interna klinika | Terminated |
| Nitra, Slovakia, 950 01 | |
| Liva - Central Military Hospital | Recruiting |
| Ruzomberok, Slovakia, 03401 | |
| Contact: Miroslav Urban, MD 421 44 438 2844 | |
| Principal Investigator: Miroslav Urban, MD | |
| NsP Prievidza so sidlom v Bojniciah | Terminated |
| Bojnice, Slovakia, 97201 | |
| Internal Dep. Hospital Žilina | Terminated |
| Žilina, Slovakia, 012 07 | |
| Sweden | |
| Universitetssjukhuset MAS | Active, not recruiting |
| Malmo, Sweden | |
| Universityetssjukhuset, Orebro | Recruiting |
| Orebro, Sweden | |
| Contact: Lena Swedberg 46 19 602 1000 | |
| Principal Investigator: Espen Fensgrud, MD | |
| Akademiska Sjukhuset, Uppsala | Recruiting |
| Uppsala, Sweden | |
| Contact: Yvonne Björkman 46 18 6112738 | |
| Principal Investigator: Per Blomstrom, MD | |
| Ukraine | |
| Donetsk Regional Clinical Hospital | Terminated |
| Donetsk, Ukraine | |
| City Clinical Hospital #8 | Terminated |
| Kharkiv, Ukraine | |
| City Clinical Hospital #9 Dept of Arrhythmia | Terminated |
| Odessa, Ukraine | |
| City Clinical Hospital #1 Intensive Care Unit | Terminated |
| Kiev, Ukraine | |
| N.D. Strazhesko Institute of Cardiology Intensive Care Unit | Terminated |
| Kiev, Ukraine | |
| Lugansk First Clinical Multiprofile Hospital #1, Cardiology | Terminated |
| Lugansk, Ukraine | |
| Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre Dept of Myocardial Infarction | Terminated |
| Lviv, Ukraine | |
| Kiev City Clinical Hospital No 5, Coronary Care Unit | Terminated |
| Kiev, Ukraine | |
| Principal Investigator: | Tomas Janota, MD | VFN III. interní klinika |
| Principal Investigator: | Christian Torp-Pedersen, MD | Gentofte Amtssygehus - Kardiologisk afdeling |
| Principal Investigator: | Rein Kolk, MD | Tartu University Hospital Heart Clinic |
| Principal Investigator: | Etienne Aliot, MD | CHU de Nancy - Hopital Brabois, Service de Cardiologie |
| Principal Investigator: | Stefan Hohnloser, MD | Johann Wolfgang Goethe Universitaet Med Klinik III - Kardiologie |
| Principal Investigator: | Heikki Huikuri, MD | Oulu University Hospital - Dept of Internal Medicine |
| Principal Investigator: | Piotr Ponikowski, MD | Osrodek Chorob Serca, Klinika Kardiologii, IV Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej we Wroclawiu |
| Principal Investigator: | Steen Juul-Moller, MD | Universitetssjukhuset MAS |
More Information
| Responsible Party: | Cardiome Pharma Corp. ( Dr Charles Fisher, Chief Medical Officer ) |
| Study ID Numbers: | VERI-305-AMIO |
| Study First Received: | April 25, 2008 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00668759 History of Changes |
| Health Authority: | Canada: Health Canada; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Estonia: The State Agency of Medicine; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Sweden: Medical Products Agency; Ukraine: Ministry of Health |
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atrial fibrillation atrial fib AF |
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Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Agents Amiodarone Pharmacologic Actions |
Pathologic Processes Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |
