Atrial Fibrillation Clinical Trial
Official title:
Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study
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).
Status | Completed |
Enrollment | 735 |
Est. completion date | July 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Comprehend and sign a written informed consent form, (per local and national regulations, as applicable) - 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 known prolonged QT syndrome or QTcB interval of >0.500 sec as measured at screening on a 12 lead ECG; familial long QT syndrome; previous Torsades de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT). - 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; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | |
Australia | Royal Hobart Hospital | Hobart | |
Australia | Launceston General Hospital | Launceston | |
Australia | Queen Elizabeth Hospital | Woodville | |
Australia | Princess Alexandra Hospital | Woolloongabba | |
Belgium | A. Z. Middelheim | Antwerp | |
Belgium | Imelda Ziekenhuis | Bonheiden | |
Belgium | U. Z. Gasthuisberg | Leuven | |
Belgium | Heilig Hart Ziekenhuis | Roeselare | |
Bulgaria | 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 | |
Croatia | General Hospital Zadar | Zadar | |
Croatia | Clinical Hospital Dubrava | Zagreb | |
Croatia | General Hospital Sveti Duh | Zagreb | |
Croatia | University Hospital " Merkur " | Zagreb | |
Czech Republic | Nemocnice Jindrichuv Hradec, a.s. | Jindrichuv Hradec | |
Czech Republic | Kromerizska Nemocnice, a.s. | Kromeriz | |
Czech Republic | Nemocnice Kutna Hora s.r.o. | Kutna Hora | |
Czech Republic | Fakultni Nemocnice Plzen | Plzen | |
Czech Republic | Vojenska Nemocnice Praha | Praha | |
Czech Republic | Vseobecna Fakultni Nemocnice v Praze | Praha | |
Czech Republic | Oblastni Nemocnice Pribram, a.s. | Pribram | |
Czech Republic | Nemocnice v Semilech | Semily | |
Czech Republic | Nemocnice Slany | Slany | |
Czech Republic | Nemocnice Tabor, a.s. | Tabor | |
Czech Republic | Nemocnice Trebic, p.o. | Trebic | |
Denmark | Bispebjerg Hospital | Copenhagen | |
Denmark | Frederiksberg Hospital | Frederiksberg | |
Denmark | Gentofte Amtssygehus | Hellerup | |
Denmark | Sygehus Vendsyssel - Hjørring | Hjorring | |
Denmark | Region Sjælland Sygehus øst Køge | Koge | |
Denmark | Kolding Sygehus | Kolding | |
Estonia | Viimsi Hospital | Haabneeme | |
Estonia | Pärnu Hospital | Parnu | |
Estonia | North Estonia Regional Hospital | Tallinn | |
Estonia | Tartu University Hospital | Tartu | |
Germany | Herzzentrum Bad Krozingen | Bad Krozingen | |
Germany | Kerckhoff-Klinik Forschungsgesellschaft mbH | Bad Nauheim | |
Germany | Evangelisches Krankenhaus | Witten | |
Hungary | 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 | Gyongyos | |
Hungary | Petz Aladár County Teaching Hospital | Gyor | |
Hungary | Bacs-Kiskun County Hospital | Kecskemet | |
Hungary | Fejér Megyei Szent György Kórház | Szekesfehervar | |
Hungary | Hetenyi Geza County Hospital | Szolnok | |
Hungary | Zala County Hospital | Zalaegerszeg | |
Lithuania | Kaunas Medical University Hospital | Kaunas | |
Lithuania | Klaipeda Seamen's Hospital | Klaipeda | |
Lithuania | Vilnius University Hospital Santariskiu Clinic | Vilnius | |
Netherlands | 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 | |
New Zealand | North Shore Hospital | Auckland | |
New Zealand | Dunedin Hospital | Dunedin | |
New Zealand | Waikato Hospital | Hamilton | |
New Zealand | Nelson Hospital | Nelson | |
Poland | SZZOZ Wielospecjalityczny Szpital Miejski im. Dr. E.Warminsk | Bydgoszcz | |
Poland | Szpital Powiatowy | Chrzanow | |
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 | Rzeszow | |
Poland | Klinika Kardiologii PAM | Szczecin | |
Poland | Szpital Specjalistyczny | Tarnow | |
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 | |
Portugal | Hospital Fernando da Fonseca | Amadora | |
Portugal | Hospital de Santa Marta | Lisbon | |
Portugal | Centro Hospitalar Vila Nova de Gaia | Vila Nova de Gaia | |
Romania | Spitalul Clinic Judetean de Urgenta Arad | Arad | |
Romania | Spitalul Clinic Judetean de Urgenta Brasov | Brasov | |
Romania | Institutul de Cardiologie C.C. Iliescu | Bucuresti | |
Romania | Spitalul Clinic Colentina | Bucuresti | |
Romania | Spitalul Clinic de Urgenta Sf. Pantelimon | Bucuresti | |
Romania | Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi | Lasi | |
Romania | Spitalul Clinic Judetean Oradea | Oradea | |
Romania | Spitalul Judetean de Urgenta Ploiesti | Ploiesti | |
Romania | Spitalul Clinic Judetean de Urgenta Targu Mures | Targu Mures | |
Romania | Spitalul Clinic Municipal de Urgenta Timisoara | Timisoara | |
Russian Federation | FSI EMC of the President of RF, b.o. City Hospital #51 | Moscow | |
Russian Federation | MedCentre of RF President, Central Clinical Hospital | Moscow | |
Russian Federation | Moscow City Hospital # 29 | Moscow | |
Russian Federation | Moscow Medical Academy. City Hospital #20 | Moscow | |
Russian Federation | Moscow SHI City Clinical Hospital #52 | Moscow | |
Russian Federation | RMA of Postg. education b.o. Botkin City Clinical Hospital | Moscow | |
Russian Federation | Russian Cardiology Research Centre | Moscow | |
Russian Federation | War Veteran's Hospital #3 | Moscow | |
Russian Federation | Pokrovskaya City Hospital | St Petersburg | |
Russian Federation | St- Petersburg GUZ City Hospital #15 | St Petersburg | |
Russian Federation | Yaroslavl Regional Clinical Hospital | Yaroslavl | |
Russian Federation | Yaroslavl State Medical Academy b.o. Clinical Hospital #2 | Yaroslavl | |
Serbia | Clinical Center of Serbia | Belgrade | |
Serbia | Dedinje Cardiovascular Institute | Belgrade | |
Serbia | Institute of CV Diseases, Clinical Center of Serbia | Belgrade | |
Serbia | Clinical Center for Cardiovascular Diseases | Niska Banja | |
Serbia | Institute of Cardiovascular Diseases Sremska Kamenica | Sremska Kamenica | |
Serbia | Clinical Center Bezanijska Kosa | Zemun | |
Serbia | Clinical Center Zemun | Zemun | |
Singapore | National Heart Center | Singapore | |
Slovakia | FNsP Bratislava - Pracovisko Stare Mesto | Bratislava | |
Slovakia | Slovensky Ustav Srdcovocievnych Chorob | Bratislava | |
Slovakia | Vychodoslovensky Ustav Srdcovocievnych Chorob | Kosice | |
Slovakia | Fakultna Nemocnica Nitra | Nitra | |
Slovakia | FNsP Nove Zamky | Nove Zamky | |
Slovakia | FNsP J. A. Reimana | Presov | |
South Africa | Clinresco Centres (Pty) Ltd | Kempton Park | |
South Africa | Vergelegen Medi-Clinic | Somerset West | |
South Africa | Clinical Project Research | Worcester | |
Spain | 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 | |
Sweden | Universitetssjukhuset Malmö | Malmo | |
Sweden | Universitetssjukhuset Örebro | Orebro | |
Sweden | Akademiska Sjukhuset | Uppsala | |
Switzerland | Universitaetsspital Basel | Basel | |
Switzerland | Kantonsspital Liestal | Liestal | |
Switzerland | Cardio Centro Ticino | Lugano | |
Switzerland | Kantonsspital St. Gallen | St Gallen | |
Ukraine | Reg.Diag.Center of Dnepr. | Dnepropetrovsk | |
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 | Kharkov | |
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 | Lugansk | |
Ukraine | Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre | Lviv | |
Ukraine | City Clinical Hospital #9 | Odessa | |
Ukraine | Hospital Therapy Dept #1of Zaporozhye SMU | Zaporizhzhya |
Lead Sponsor | Collaborator |
---|---|
Cardiome Pharma |
Australia, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Germany, Hungary, Lithuania, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first documented recurrence of symptomatic sustained AF. | Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing | No | |
Primary | Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events | Safety assessments within Day 120 of dosing | Yes | |
Secondary | 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 | No | |
Secondary | Time to first documented recurrence of symptomatic AF | Time to first documented recurrence of symptomatic AF within 90 days of dosing | No | |
Secondary | 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 | No | |
Secondary | Proportion of subjects in sinus rhythm on Day 90. | Proportion of subjects in sinus rhythm on Day 90 of dosing | No | |
Secondary | 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 | No | |
Secondary | Improvement in QOL as measured by SF-36 | Improvement in QOL as measured by SF-36 within Day 90 of dosing | No |
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