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Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Vernakalant (oral)
Sponsored by
Advanz Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Royal Adelaide Hospital
  • Royal Hobart Hospital
  • Launceston General Hospital
  • Queen Elizabeth Hospital
  • Princess Alexandra Hospital
  • A. Z. Middelheim
  • Imelda Ziekenhuis
  • U. Z. Gasthuisberg
  • Heilig Hart Ziekenhuis
  • MHAT - Haskovo
  • UMHAT 'Dr. Georgi Stranski'
  • MHAT 'Rouse AD'
  • IV MHAT
  • MHAT 'Tzaritza Yoanna'
  • MI Central Clinical Base - Ministry of Interior
  • Military Medical Academy
  • MHAT 'Sveta Marina'
  • MMA - Hospital Base for Active Treatment - Varna
  • General Hospital Zadar
  • Clinical Hospital Dubrava
  • General Hospital Sveti Duh
  • University Hospital " Merkur "
  • Nemocnice Jindrichuv Hradec, a.s.
  • Kromerizska Nemocnice, a.s.
  • Nemocnice Kutna Hora s.r.o.
  • Fakultni Nemocnice Plzen
  • Vojenska Nemocnice Praha
  • Vseobecna Fakultni Nemocnice v Praze
  • Oblastni Nemocnice Pribram, a.s.
  • Nemocnice v Semilech
  • Nemocnice Slany
  • Nemocnice Tabor, a.s.
  • Nemocnice Trebic, p.o.
  • Bispebjerg Hospital
  • Frederiksberg Hospital
  • Gentofte Amtssygehus
  • Sygehus Vendsyssel - Hjørring
  • Region Sjælland Sygehus øst Køge
  • Kolding Sygehus
  • Viimsi Hospital
  • Pärnu Hospital
  • North Estonia Regional Hospital
  • Tartu University Hospital
  • Herzzentrum Bad Krozingen
  • Kerckhoff-Klinik Forschungsgesellschaft mbH
  • Evangelisches Krankenhaus
  • Magyar Imre Hospital
  • Baja City Community Hospital
  • Nyiro Gyula Hospital
  • Péterfy Sándor Hospital
  • Szent Istvan Hospital
  • Bugat Pal Hospital
  • Petz Aladár County Teaching Hospital
  • Bacs-Kiskun County Hospital
  • Fejér Megyei Szent György Kórház
  • Hetenyi Geza County Hospital
  • Zala County Hospital
  • Kaunas Medical University Hospital
  • Klaipeda Seamen's Hospital
  • Vilnius University Hospital Santariskiu Clinic
  • VU Medisch Centrum
  • Reinier de Graaf Groep
  • Catharina Ziekenhuis
  • Martini Ziekenhuis
  • Academisch Ziekenhuis Maastricht
  • Stichting Sint Antonius Ziekenhuis
  • Isala Klinieken
  • North Shore Hospital
  • Dunedin Hospital
  • Waikato Hospital
  • Nelson Hospital
  • SZZOZ Wielospecjalityczny Szpital Miejski im. Dr. E.Warminsk
  • Szpital Powiatowy
  • Instytut Kardiologii AMG
  • Szpital Miejski w Gdyni
  • Zaklad Farmakologii i Terapii Monitorowanej z Oddzialem Chor
  • SP ZOZ Okregowy Szpital Kolejowy
  • Szpital Wojewodzki Nr 2
  • Klinika Kardiologii PAM
  • Szpital Specjalistyczny
  • III Klinika Chorob Wewnetrznych i Kardiologii
  • Wojskowy Instytut Medyczny, CSK MON
  • Osrodek Chorob Serca, 4Wojskowy Szpital Kliniczny z Poliklin
  • Hospital Fernando da Fonseca
  • Hospital de Santa Marta
  • Centro Hospitalar Vila Nova de Gaia
  • Spitalul Clinic Judetean de Urgenta Arad
  • Spitalul Clinic Judetean de Urgenta Brasov
  • Institutul de Cardiologie C.C. Iliescu
  • Spitalul Clinic Colentina
  • Spitalul Clinic de Urgenta Sf. Pantelimon
  • Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi
  • Spitalul Clinic Judetean Oradea
  • Spitalul Judetean de Urgenta Ploiesti
  • Spitalul Clinic Judetean de Urgenta Targu Mures
  • Spitalul Clinic Municipal de Urgenta Timisoara
  • FSI EMC of the President of RF, b.o. City Hospital #51
  • MedCentre of RF President, Central Clinical Hospital
  • Moscow City Hospital # 29
  • Moscow Medical Academy. City Hospital #20
  • Moscow SHI City Clinical Hospital #52
  • RMA of Postg. education b.o. Botkin City Clinical Hospital
  • Russian Cardiology Research Centre
  • War Veteran's Hospital #3
  • Pokrovskaya City Hospital
  • St- Petersburg GUZ City Hospital #15
  • Yaroslavl Regional Clinical Hospital
  • Yaroslavl State Medical Academy b.o. Clinical Hospital #2
  • Clinical Center of Serbia
  • Dedinje Cardiovascular Institute
  • Institute of CV Diseases, Clinical Center of Serbia
  • Clinical Center for Cardiovascular Diseases
  • Institute of Cardiovascular Diseases Sremska Kamenica
  • Clinical Center Bezanijska Kosa
  • Clinical Center Zemun
  • National Heart Center
  • FNsP Bratislava - Pracovisko Stare Mesto
  • Slovensky Ustav Srdcovocievnych Chorob
  • Vychodoslovensky Ustav Srdcovocievnych Chorob
  • Fakultna Nemocnica Nitra
  • FNsP Nove Zamky
  • FNsP J. A. Reimana
  • Clinresco Centres (Pty) Ltd
  • Vergelegen Medi-Clinic
  • Clinical Project Research
  • Hospital Vall D'Hebron
  • Hosp. Virgen de las Nieves
  • Clinica Universitaria Puerta de Hierro
  • Hosp. Clinico San Carlos
  • Hospital Ramon y Cajal
  • Hospital Universitario La Paz
  • Hospital Univ. Tarragona Joan XXIII
  • Universitetssjukhuset Malmö
  • Universitetssjukhuset Örebro
  • Akademiska Sjukhuset
  • Universitaetsspital Basel
  • Kantonsspital Liestal
  • Cardio Centro Ticino
  • Kantonsspital St. Gallen
  • Reg.Diag.Center of Dnepr.
  • Cent.City Clin.Hosp.#3.Chair of Int.Dis.#2 of Donetsk SMU
  • Donetsk Regional Clinical Hospital
  • City Clinical Hospital #8
  • City Clinical Hospital #1
  • Kiev City Clinical Hospital No 5, Coronary Care Unit
  • Kiev Clinical Emergency Care Hospital
  • M.D.Strazhesko Institut of Cardiology
  • N.D. Strazhesko Institute of Cardiology
  • Lugansk First Clinical Multiprofile Hospital #1, cardiology
  • Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre
  • City Clinical Hospital #9
  • Hospital Therapy Dept #1of Zaporozhye SMU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Placebo (b.i.d.)

Vernakalant (oral), 150 mg (b.i.d.)

Vernakalant (oral), 300 mg (b.i.d.)

Vernakalant (oral), 500 mg (b.i.d.)

Outcomes

Primary Outcome Measures

Time to first documented recurrence of symptomatic sustained AF.
Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events

Secondary Outcome Measures

Time to first documented recurrence of symptomatic or asymptomatic sustained AF
Time to first documented recurrence of symptomatic AF
Time to first documented recurrence of symptomatic or asymptomatic AF
Proportion of subjects in sinus rhythm on Day 90.
Improvement in AF symptoms as assessed by an AF symptom checklist.
Improvement in QOL as measured by SF-36

Full Information

First Posted
September 5, 2007
Last Updated
December 17, 2008
Sponsor
Advanz Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00526136
Brief Title
Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study
Official Title
Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Advanz Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
735 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo (b.i.d.)
Arm Title
2
Arm Type
Experimental
Arm Description
Vernakalant (oral), 150 mg (b.i.d.)
Arm Title
3
Arm Type
Experimental
Arm Description
Vernakalant (oral), 300 mg (b.i.d.)
Arm Title
4
Arm Type
Experimental
Arm Description
Vernakalant (oral), 500 mg (b.i.d.)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Vernakalant (oral)
Other Intervention Name(s)
RSD1235-SR
Intervention Description
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Primary Outcome Measure Information:
Title
Time to first documented recurrence of symptomatic sustained AF.
Time Frame
Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing
Title
Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events
Time Frame
Safety assessments within Day 120 of dosing
Secondary Outcome Measure Information:
Title
Time to first documented recurrence of symptomatic or asymptomatic sustained AF
Time Frame
Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing
Title
Time to first documented recurrence of symptomatic AF
Time Frame
Time to first documented recurrence of symptomatic AF within 90 days of dosing
Title
Time to first documented recurrence of symptomatic or asymptomatic AF
Time Frame
Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing
Title
Proportion of subjects in sinus rhythm on Day 90.
Time Frame
Proportion of subjects in sinus rhythm on Day 90 of dosing
Title
Improvement in AF symptoms as assessed by an AF symptom checklist.
Time Frame
Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing
Title
Improvement in QOL as measured by SF-36
Time Frame
Improvement in QOL as measured by SF-36 within Day 90 of dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Beatch, PhD
Organizational Affiliation
Advanz Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
Country
Australia
Facility Name
A. Z. Middelheim
City
Antwerp
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
U. Z. Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Heilig Hart Ziekenhuis
City
Roeselare
Country
Belgium
Facility Name
MHAT - Haskovo
City
Haskovo
Country
Bulgaria
Facility Name
UMHAT 'Dr. Georgi Stranski'
City
Pleven
Country
Bulgaria
Facility Name
MHAT 'Rouse AD'
City
Rousse
Country
Bulgaria
Facility Name
IV MHAT
City
Sofia
Country
Bulgaria
Facility Name
MHAT 'Tzaritza Yoanna'
City
Sofia
Country
Bulgaria
Facility Name
MI Central Clinical Base - Ministry of Interior
City
Sofia
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
Country
Bulgaria
Facility Name
MHAT 'Sveta Marina'
City
Varna
Country
Bulgaria
Facility Name
MMA - Hospital Base for Active Treatment - Varna
City
Varna
Country
Bulgaria
Facility Name
General Hospital Zadar
City
Zadar
Country
Croatia
Facility Name
Clinical Hospital Dubrava
City
Zagreb
Country
Croatia
Facility Name
General Hospital Sveti Duh
City
Zagreb
Country
Croatia
Facility Name
University Hospital " Merkur "
City
Zagreb
Country
Croatia
Facility Name
Nemocnice Jindrichuv Hradec, a.s.
City
Jindrichuv Hradec
Country
Czech Republic
Facility Name
Kromerizska Nemocnice, a.s.
City
Kromeriz
Country
Czech Republic
Facility Name
Nemocnice Kutna Hora s.r.o.
City
Kutna Hora
Country
Czech Republic
Facility Name
Fakultni Nemocnice Plzen
City
Plzen
Country
Czech Republic
Facility Name
Vojenska Nemocnice Praha
City
Praha
Country
Czech Republic
Facility Name
Vseobecna Fakultni Nemocnice v Praze
City
Praha
Country
Czech Republic
Facility Name
Oblastni Nemocnice Pribram, a.s.
City
Pribram
Country
Czech Republic
Facility Name
Nemocnice v Semilech
City
Semily
Country
Czech Republic
Facility Name
Nemocnice Slany
City
Slany
Country
Czech Republic
Facility Name
Nemocnice Tabor, a.s.
City
Tabor
Country
Czech Republic
Facility Name
Nemocnice Trebic, p.o.
City
Trebic
Country
Czech Republic
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Facility Name
Frederiksberg Hospital
City
Frederiksberg
Country
Denmark
Facility Name
Gentofte Amtssygehus
City
Hellerup
Country
Denmark
Facility Name
Sygehus Vendsyssel - Hjørring
City
Hjorring
Country
Denmark
Facility Name
Region Sjælland Sygehus øst Køge
City
Koge
Country
Denmark
Facility Name
Kolding Sygehus
City
Kolding
Country
Denmark
Facility Name
Viimsi Hospital
City
Haabneeme
Country
Estonia
Facility Name
Pärnu Hospital
City
Parnu
Country
Estonia
Facility Name
North Estonia Regional Hospital
City
Tallinn
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Kerckhoff-Klinik Forschungsgesellschaft mbH
City
Bad Nauheim
Country
Germany
Facility Name
Evangelisches Krankenhaus
City
Witten
Country
Germany
Facility Name
Magyar Imre Hospital
City
Ajka
Country
Hungary
Facility Name
Baja City Community Hospital
City
Baja
Country
Hungary
Facility Name
Nyiro Gyula Hospital
City
Budapest
Country
Hungary
Facility Name
Péterfy Sándor Hospital
City
Budapest
Country
Hungary
Facility Name
Szent Istvan Hospital
City
Budapest
Country
Hungary
Facility Name
Bugat Pal Hospital
City
Gyongyos
Country
Hungary
Facility Name
Petz Aladár County Teaching Hospital
City
Gyor
Country
Hungary
Facility Name
Bacs-Kiskun County Hospital
City
Kecskemet
Country
Hungary
Facility Name
Fejér Megyei Szent György Kórház
City
Szekesfehervar
Country
Hungary
Facility Name
Hetenyi Geza County Hospital
City
Szolnok
Country
Hungary
Facility Name
Zala County Hospital
City
Zalaegerszeg
Country
Hungary
Facility Name
Kaunas Medical University Hospital
City
Kaunas
Country
Lithuania
Facility Name
Klaipeda Seamen's Hospital
City
Klaipeda
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinic
City
Vilnius
Country
Lithuania
Facility Name
VU Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Reinier de Graaf Groep
City
Delft
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
Country
Netherlands
Facility Name
Stichting Sint Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Facility Name
North Shore Hospital
City
Auckland
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Nelson Hospital
City
Nelson
Country
New Zealand
Facility Name
SZZOZ Wielospecjalityczny Szpital Miejski im. Dr. E.Warminsk
City
Bydgoszcz
Country
Poland
Facility Name
Szpital Powiatowy
City
Chrzanow
Country
Poland
Facility Name
Instytut Kardiologii AMG
City
Gdansk
Country
Poland
Facility Name
Szpital Miejski w Gdyni
City
Gdynia
Country
Poland
Facility Name
Zaklad Farmakologii i Terapii Monitorowanej z Oddzialem Chor
City
Lodz
Country
Poland
Facility Name
SP ZOZ Okregowy Szpital Kolejowy
City
Lublin
Country
Poland
Facility Name
Szpital Wojewodzki Nr 2
City
Rzeszow
Country
Poland
Facility Name
Klinika Kardiologii PAM
City
Szczecin
Country
Poland
Facility Name
Szpital Specjalistyczny
City
Tarnow
Country
Poland
Facility Name
III Klinika Chorob Wewnetrznych i Kardiologii
City
Warsaw
Country
Poland
Facility Name
Wojskowy Instytut Medyczny, CSK MON
City
Warsaw
Country
Poland
Facility Name
Osrodek Chorob Serca, 4Wojskowy Szpital Kliniczny z Poliklin
City
Wroclaw
Country
Poland
Facility Name
Hospital Fernando da Fonseca
City
Amadora
Country
Portugal
Facility Name
Hospital de Santa Marta
City
Lisbon
Country
Portugal
Facility Name
Centro Hospitalar Vila Nova de Gaia
City
Vila Nova de Gaia
Country
Portugal
Facility Name
Spitalul Clinic Judetean de Urgenta Arad
City
Arad
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Brasov
City
Brasov
Country
Romania
Facility Name
Institutul de Cardiologie C.C. Iliescu
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic de Urgenta Sf. Pantelimon
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi
City
Lasi
Country
Romania
Facility Name
Spitalul Clinic Judetean Oradea
City
Oradea
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Ploiesti
City
Ploiesti
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures
City
Targu Mures
Country
Romania
Facility Name
Spitalul Clinic Municipal de Urgenta Timisoara
City
Timisoara
Country
Romania
Facility Name
FSI EMC of the President of RF, b.o. City Hospital #51
City
Moscow
Country
Russian Federation
Facility Name
MedCentre of RF President, Central Clinical Hospital
City
Moscow
Country
Russian Federation
Facility Name
Moscow City Hospital # 29
City
Moscow
Country
Russian Federation
Facility Name
Moscow Medical Academy. City Hospital #20
City
Moscow
Country
Russian Federation
Facility Name
Moscow SHI City Clinical Hospital #52
City
Moscow
Country
Russian Federation
Facility Name
RMA of Postg. education b.o. Botkin City Clinical Hospital
City
Moscow
Country
Russian Federation
Facility Name
Russian Cardiology Research Centre
City
Moscow
Country
Russian Federation
Facility Name
War Veteran's Hospital #3
City
Moscow
Country
Russian Federation
Facility Name
Pokrovskaya City Hospital
City
St Petersburg
Country
Russian Federation
Facility Name
St- Petersburg GUZ City Hospital #15
City
St Petersburg
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Hospital
City
Yaroslavl
Country
Russian Federation
Facility Name
Yaroslavl State Medical Academy b.o. Clinical Hospital #2
City
Yaroslavl
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
Country
Serbia
Facility Name
Dedinje Cardiovascular Institute
City
Belgrade
Country
Serbia
Facility Name
Institute of CV Diseases, Clinical Center of Serbia
City
Belgrade
Country
Serbia
Facility Name
Clinical Center for Cardiovascular Diseases
City
Niska Banja
Country
Serbia
Facility Name
Institute of Cardiovascular Diseases Sremska Kamenica
City
Sremska Kamenica
Country
Serbia
Facility Name
Clinical Center Bezanijska Kosa
City
Zemun
Country
Serbia
Facility Name
Clinical Center Zemun
City
Zemun
Country
Serbia
Facility Name
National Heart Center
City
Singapore
Country
Singapore
Facility Name
FNsP Bratislava - Pracovisko Stare Mesto
City
Bratislava
Country
Slovakia
Facility Name
Slovensky Ustav Srdcovocievnych Chorob
City
Bratislava
Country
Slovakia
Facility Name
Vychodoslovensky Ustav Srdcovocievnych Chorob
City
Kosice
Country
Slovakia
Facility Name
Fakultna Nemocnica Nitra
City
Nitra
Country
Slovakia
Facility Name
FNsP Nove Zamky
City
Nove Zamky
Country
Slovakia
Facility Name
FNsP J. A. Reimana
City
Presov
Country
Slovakia
Facility Name
Clinresco Centres (Pty) Ltd
City
Kempton Park
Country
South Africa
Facility Name
Vergelegen Medi-Clinic
City
Somerset West
Country
South Africa
Facility Name
Clinical Project Research
City
Worcester
Country
South Africa
Facility Name
Hospital Vall D'Hebron
City
Barcelona
Country
Spain
Facility Name
Hosp. Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Clinica Universitaria Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Univ. Tarragona Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Universitetssjukhuset Malmö
City
Malmo
Country
Sweden
Facility Name
Universitetssjukhuset Örebro
City
Orebro
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
Country
Sweden
Facility Name
Universitaetsspital Basel
City
Basel
Country
Switzerland
Facility Name
Kantonsspital Liestal
City
Liestal
Country
Switzerland
Facility Name
Cardio Centro Ticino
City
Lugano
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St Gallen
Country
Switzerland
Facility Name
Reg.Diag.Center of Dnepr.
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Cent.City Clin.Hosp.#3.Chair of Int.Dis.#2 of Donetsk SMU
City
Donetsk
Country
Ukraine
Facility Name
Donetsk Regional Clinical Hospital
City
Donetsk
Country
Ukraine
Facility Name
City Clinical Hospital #8
City
Kharkov
Country
Ukraine
Facility Name
City Clinical Hospital #1
City
Kiev
Country
Ukraine
Facility Name
Kiev City Clinical Hospital No 5, Coronary Care Unit
City
Kiev
Country
Ukraine
Facility Name
Kiev Clinical Emergency Care Hospital
City
Kiev
Country
Ukraine
Facility Name
M.D.Strazhesko Institut of Cardiology
City
Kiev
Country
Ukraine
Facility Name
N.D. Strazhesko Institute of Cardiology
City
Kiev
Country
Ukraine
Facility Name
Lugansk First Clinical Multiprofile Hospital #1, cardiology
City
Lugansk
Country
Ukraine
Facility Name
Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre
City
Lviv
Country
Ukraine
Facility Name
City Clinical Hospital #9
City
Odessa
Country
Ukraine
Facility Name
Hospital Therapy Dept #1of Zaporozhye SMU
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
21841207
Citation
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.
Results Reference
derived
Links:
URL
http://www.cardiome.com
Description
Related Info

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Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

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