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

This study has been completed.
Sponsor:
Information provided by:
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT00526136
First received: September 5, 2007
Last updated: December 17, 2008
Last verified: December 2008
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Drug: Placebo
Drug: Vernakalant (oral)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

Resource links provided by NLM:


Further study details as provided by Cardiome Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Time to first documented recurrence of symptomatic AF [ Time Frame: Time to first documented recurrence of symptomatic AF within 90 days of dosing ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects in sinus rhythm on Day 90. [ Time Frame: Proportion of subjects in sinus rhythm on Day 90 of dosing ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Improvement in QOL as measured by SF-36 [ Time Frame: Improvement in QOL as measured by SF-36 within Day 90 of dosing ] [ Designated as safety issue: No ]

Enrollment: 735
Study Start Date: March 2007
Study Completion Date: July 2008
Arms Assigned Interventions
Placebo Comparator: 1
Placebo (b.i.d.)
Drug: Placebo
Experimental: 2
Vernakalant (oral), 150 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Name: RSD1235-SR
Experimental: 3
Vernakalant (oral), 300 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Name: RSD1235-SR
Experimental: 4
Vernakalant (oral), 500 mg (b.i.d.)
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
Other Name: RSD1235-SR

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526136

  Hide Study Locations
Locations
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, Australia
Belgium
A. Z. Middelheim
Antwerp, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
U. Z. Gasthuisberg
Leuven, Belgium
Heilig Hart Ziekenhuis
Roeselare, Belgium
Bulgaria
MHAT - Haskovo
Haskovo, Bulgaria
UMHAT 'Dr. Georgi Stranski'
Pleven, Bulgaria
MHAT 'Rouse AD'
Rousse, Bulgaria
Military Medical Academy
Sofia, Bulgaria
MI Central Clinical Base - Ministry of Interior
Sofia, Bulgaria
MHAT 'Tzaritza Yoanna'
Sofia, Bulgaria
IV MHAT
Sofia, Bulgaria
MMA - Hospital Base for Active Treatment - Varna
Varna, Bulgaria
MHAT 'Sveta Marina'
Varna, Bulgaria
Croatia
General Hospital Zadar
Zadar, Croatia
Clinical Hospital Dubrava
Zagreb, Croatia
University Hospital " Merkur "
Zagreb, Croatia
General Hospital Sveti Duh
Zagreb, Croatia
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
Vseobecna Fakultni Nemocnice v Praze
Praha, Czech Republic
Vojenska Nemocnice Praha
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, Czech Republic
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, Denmark
Estonia
Viimsi Hospital
Haabneeme, Estonia
Pärnu Hospital
Parnu, Estonia
North Estonia Regional Hospital
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, Germany
Evangelisches Krankenhaus
Witten, Germany
Hungary
Magyar Imre Hospital
Ajka, Hungary
Baja City Community Hospital
Baja, Hungary
Szent Istvan Hospital
Budapest, Hungary
Péterfy Sándor Hospital
Budapest, Hungary
Nyiro Gyula 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, Hungary
Lithuania
Kaunas Medical University Hospital
Kaunas, Lithuania
Klaipeda Seamen's Hospital
Klaipeda, Lithuania
Vilnius University Hospital Santariskiu Clinic
Vilnius, Lithuania
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, Netherlands
New Zealand
North Shore Hospital
Auckland, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand
Nelson Hospital
Nelson, New Zealand
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, Poland
Portugal
Hospital Fernando da Fonseca
Amadora, Portugal
Hospital de Santa Marta
Lisbon, Portugal
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, Portugal
Romania
Spitalul Clinic Judetean de Urgenta Arad
Arad, Romania
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, Romania
Spitalul Clinic Colentina
Bucuresti, Romania
Institutul de Cardiologie C.C. Iliescu
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, Romania
Russian Federation
Russian Cardiology Research Centre
Moscow, Russian Federation
War Veteran's Hospital #3
Moscow, Russian Federation
FSI EMC of the President of RF, b.o. City Hospital #51
Moscow, Russian Federation
Moscow Medical Academy. City Hospital #20
Moscow, Russian Federation
Moscow City Hospital # 29
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
MedCentre of RF President, Central Clinical Hospital
Moscow, Russian Federation
Pokrovskaya City Hospital
St Petersburg, Russian Federation
St- Petersburg GUZ City Hospital #15
St Petersburg, Russian Federation
Yaroslavl State Medical Academy b.o. Clinical Hospital #2
Yaroslavl, Russian Federation
Yaroslavl Regional Clinical Hospital
Yaroslavl, Russian Federation
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 Zemun
Zemun, Serbia
Clinical Center Bezanijska Kosa
Zemun, Serbia
Singapore
National Heart Center
Singapore, Singapore
Slovakia
Slovensky Ustav Srdcovocievnych Chorob
Bratislava, Slovakia
FNsP Bratislava - Pracovisko Stare Mesto
Bratislava, Slovakia
Vychodoslovensky Ustav Srdcovocievnych Chorob
Kosice, Slovakia
Fakultna Nemocnica Nitra
Nitra, Slovakia
FNsP Nove Zamky
Nove Zamky, Slovakia
FNsP J. A. Reimana
Presov, Slovakia
South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, South Africa
Vergelegen Medi-Clinic
Somerset West, South Africa
Clinical Project Research
Worcester, South Africa
Spain
Hospital Vall D'Hebron
Barcelona, Spain
Hosp. Virgen de las Nieves
Granada, Spain
Hospital Ramon y Cajal
Madrid, Spain
Clinica Universitaria Puerta de Hierro
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hosp. Clinico San Carlos
Madrid, Spain
Hospital Univ. Tarragona Joan XXIII
Tarragona, Spain
Sweden
Universitetssjukhuset Malmö
Malmo, Sweden
Universitetssjukhuset Örebro
Orebro, Sweden
Akademiska Sjukhuset
Uppsala, Sweden
Switzerland
Universitaetsspital Basel
Basel, Switzerland
Kantonsspital Liestal
Liestal, Switzerland
Cardio Centro Ticino
Lugano, Switzerland
Kantonsspital St. Gallen
St Gallen, Switzerland
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
Kiev City Clinical Hospital No 5, Coronary Care Unit
Kiev, Ukraine
Kiev Clinical Emergency Care Hospital
Kiev, Ukraine
N.D. Strazhesko Institute of Cardiology
Kiev, Ukraine
M.D.Strazhesko Institut of Cardiology
Kiev, Ukraine
City Clinical Hospital #1
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, Ukraine
Sponsors and Collaborators
Cardiome Pharma
Investigators
Study Director: Gregory Beatch, PhD Cardiome Pharma
  More Information

Additional Information:
No publications provided by Cardiome Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp.
ClinicalTrials.gov Identifier: NCT00526136     History of Changes
Other Study ID Numbers: 1235-SR-202-AF
Study First Received: September 5, 2007
Last Updated: December 17, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
New Zealand: Medsafe
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: Ministry of Public Health
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Swissmedic
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Cardiome Pharma:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on July 24, 2014