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Atrial FibrillationPhase 2NCT00526136

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

A Phase 2 study testing Vernakalant (oral) in people with Atrial Fibrillation, run by Advanz Pharma at 152 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Vernakalant (oral)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
735 participants
Where
152 sitesin 24 countries
Study dates
Mar 2007to Jul 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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;
Show all 14Show fewer
  • 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;

Trial locations and contacts

152 sites in 24 countries.

152 sites in 24 countries

Ukraine13 sites

  • Reg.Diag.Center of Dnepr.

    Dnipro

  • Cent.City Clin.Hosp.#3.Chair of Int.Dis.#2 of Donetsk SMU

    Donetsk

  • Donetsk Regional Clinical Hospital

    Donetsk

  • City Clinical Hospital #8

    Kharkiv

  • City Clinical Hospital #1

    Kiev

  • Kiev City Clinical Hospital No 5, Coronary Care Unit

    Kiev

  • Kiev Clinical Emergency Care Hospital

    Kiev

  • M.D.Strazhesko Institut of Cardiology

    Kiev

  • N.D. Strazhesko Institute of Cardiology

    Kiev

  • Lugansk First Clinical Multiprofile Hospital #1, cardiology

    Luhansk

  • Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre

    Lviv

  • City Clinical Hospital #9

    Odesa

  • Hospital Therapy Dept #1of Zaporozhye SMU

    Zaporizhzhya

Other trials in Ukraine

Poland12 sites

  • SZZOZ Wielospecjalityczny Szpital Miejski im. Dr. E.Warminsk

    Bydgoszcz

  • Szpital Powiatowy

    Chrzanów

  • Instytut Kardiologii AMG

    Gdansk

  • Szpital Miejski w Gdyni

    Gdynia

  • Zaklad Farmakologii i Terapii Monitorowanej z Oddzialem Chor

    Lodz

  • SP ZOZ Okregowy Szpital Kolejowy

    Lublin

  • Szpital Wojewodzki Nr 2

    Rzeszów

  • Klinika Kardiologii PAM

    Szczecin

  • Szpital Specjalistyczny

    Tarnów

  • III Klinika Chorob Wewnetrznych i Kardiologii

    Warsaw

  • Wojskowy Instytut Medyczny, CSK MON

    Warsaw

  • Osrodek Chorob Serca, 4Wojskowy Szpital Kliniczny z Poliklin

    Wroclaw

Other trials in Poland

Russia12 sites

  • FSI EMC of the President of RF, b.o. City Hospital #51

    Moscow

  • MedCentre of RF President, Central Clinical Hospital

    Moscow

  • Moscow City Hospital # 29

    Moscow

  • Moscow Medical Academy. City Hospital #20

    Moscow

  • Moscow SHI City Clinical Hospital #52

    Moscow

  • RMA of Postg. education b.o. Botkin City Clinical Hospital

    Moscow

  • Russian Cardiology Research Centre

    Moscow

  • War Veteran's Hospital #3

    Moscow

  • Pokrovskaya City Hospital

    Saint Petersburg

  • St- Petersburg GUZ City Hospital #15

    Saint Petersburg

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl

  • Yaroslavl State Medical Academy b.o. Clinical Hospital #2

    Yaroslavl

Other trials in Russia

Czechia11 sites

  • Nemocnice Jindrichuv Hradec, a.s.

    Jindřichův Hradec

  • Kromerizska Nemocnice, a.s.

    Kroměříž

  • Nemocnice Kutna Hora s.r.o.

    Kutná Hora

  • Fakultni Nemocnice Plzen

    Pilsen

  • Vojenska Nemocnice Praha

    Prague

  • Vseobecna Fakultni Nemocnice v Praze

    Prague

  • Oblastni Nemocnice Pribram, a.s.

    Příbram

  • Nemocnice v Semilech

    Semily

  • Nemocnice Slany

    Slaný

  • Nemocnice Tabor, a.s.

    Tábor

  • Nemocnice Trebic, p.o.

    Třebíč

Other trials in Czechia

Hungary11 sites

  • Magyar Imre Hospital

    Ajka

  • Baja City Community Hospital

    Baja

  • Nyiro Gyula Hospital

    Budapest

  • Péterfy Sándor Hospital

    Budapest

  • Szent Istvan Hospital

    Budapest

  • Bugat Pal Hospital

    Gyöngyös

  • Petz Aladár County Teaching Hospital

    Győr

  • Bacs-Kiskun County Hospital

    Kecskemét

  • Fejér Megyei Szent György Kórház

    Székesfehérvár

  • Hetenyi Geza County Hospital

    Szolnok

  • Zala County Hospital

    Zalaegerszeg

Other trials in Hungary

Romania10 sites

  • Spitalul Clinic Judetean de Urgenta Arad

    Arad

  • Spitalul Clinic Judetean de Urgenta Brasov

    Brasov

  • Institutul de Cardiologie C.C. Iliescu

    Bucharest

  • Spitalul Clinic Colentina

    Bucharest

  • Spitalul Clinic de Urgenta Sf. Pantelimon

    Bucharest

  • Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi

    Lasi

  • Spitalul Clinic Judetean Oradea

    Oradea

  • Spitalul Judetean de Urgenta Ploiesti

    Ploieşti

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Târgu Mureş

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara

Other trials in Romania

Bulgaria9 sites

  • MHAT - Haskovo

    Haskovo

  • UMHAT 'Dr. Georgi Stranski'

    Pleven

  • MHAT 'Rouse AD'

    Rousse

  • IV MHAT

    Sofia

  • MHAT 'Tzaritza Yoanna'

    Sofia

  • MI Central Clinical Base - Ministry of Interior

    Sofia

  • Military Medical Academy

    Sofia

  • MHAT 'Sveta Marina'

    Varna

  • MMA - Hospital Base for Active Treatment - Varna

    Varna

Other trials in Bulgaria

Netherlands7 sites

  • VU Medisch Centrum

    Amsterdam

  • Reinier de Graaf Groep

    Delft

  • Catharina Ziekenhuis

    Eindhoven

  • Martini Ziekenhuis

    Groningen

  • Academisch Ziekenhuis Maastricht

    Maastricht

  • Stichting Sint Antonius Ziekenhuis

    Nieuwegein

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

Serbia7 sites

  • Clinical Center of Serbia

    Belgrade

  • Dedinje Cardiovascular Institute

    Belgrade

  • Institute of CV Diseases, Clinical Center of Serbia

    Belgrade

  • Institute of Cardiovascular Diseases Sremska Kamenica

    Kamenitz

  • Clinical Center for Cardiovascular Diseases

    Niška Banja

  • Clinical Center Bezanijska Kosa

    Zemun

  • Clinical Center Zemun

    Zemun

Other trials in Serbia

Spain7 sites

  • Hospital Vall D'Hebron

    Barcelona

  • Hosp. Virgen de las Nieves

    Granada

  • Clinica Universitaria Puerta de Hierro

    Madrid

  • Hosp. Clinico San Carlos

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Univ. Tarragona Joan XXIII

    Tarragona

Other trials in Spain

Denmark6 sites

  • Bispebjerg Hospital

    Copenhagen

  • Frederiksberg Hospital

    Frederiksberg

  • Gentofte Amtssygehus

    Hellerup

  • Sygehus Vendsyssel - Hjørring

    Hjørring

  • Region Sjælland Sygehus øst Køge

    Køge

  • Kolding Sygehus

    Kolding

Other trials in Denmark

Slovakia6 sites

  • FNsP Bratislava - Pracovisko Stare Mesto

    Bratislava

  • Slovensky Ustav Srdcovocievnych Chorob

    Bratislava

  • Vychodoslovensky Ustav Srdcovocievnych Chorob

    Košice

  • Fakultna Nemocnica Nitra

    Nitra

  • FNsP Nove Zamky

    Nové Zámky

  • FNsP J. A. Reimana

    Prešov

Other trials in Slovakia

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide

  • Royal Hobart Hospital

    Hobart

  • Launceston General Hospital

    Launceston

  • Queen Elizabeth Hospital

    Woodville

  • Princess Alexandra Hospital

    Woolloongabba

Other trials in Australia

Belgium4 sites

  • A. Z. Middelheim

    Antwerp

  • Imelda Ziekenhuis

    Bonheiden

  • U. Z. Gasthuisberg

    Leuven

  • Heilig Hart Ziekenhuis

    Roeselare

Other trials in Belgium

Croatia4 sites

  • General Hospital Zadar

    Zadar

  • Clinical Hospital Dubrava

    Zagreb

  • General Hospital Sveti Duh

    Zagreb

  • University Hospital " Merkur "

    Zagreb

Other trials in Croatia

Estonia4 sites

  • Viimsi Hospital

    Haabneeme

  • Pärnu Hospital

    Pärnu

  • North Estonia Regional Hospital

    Tallinn

  • Tartu University Hospital

    Tartu

Other trials in Estonia

New Zealand4 sites

  • North Shore Hospital

    Auckland

  • Dunedin Hospital

    Dunedin

  • Waikato Hospital

    Hamilton

  • Nelson Hospital

    Nelson

Other trials in New Zealand

Switzerland4 sites

  • Universitaetsspital Basel

    Basel

  • Kantonsspital Liestal

    Liestal

  • Cardio Centro Ticino

    Lugano

  • Kantonsspital St. Gallen

    Sankt Gallen

Other trials in Switzerland

Germany3 sites

  • Herzzentrum Bad Krozingen

    Bad Krozingen

  • Kerckhoff-Klinik Forschungsgesellschaft mbH

    Bad Nauheim

  • Evangelisches Krankenhaus

    Witten

Other trials in Germany

Lithuania3 sites

  • Kaunas Medical University Hospital

    Kaunas

  • Klaipeda Seamen's Hospital

    Klaipėda

  • Vilnius University Hospital Santariskiu Clinic

    Vilnius

Other trials in Lithuania

Portugal3 sites

  • Hospital Fernando da Fonseca

    Amadora

  • Hospital de Santa Marta

    Lisbon

  • Centro Hospitalar Vila Nova de Gaia

    Vila Nova de Gaia

Other trials in Portugal

South Africa3 sites

  • Clinresco Centres (Pty) Ltd

    Kempton Park

  • Vergelegen Medi-Clinic

    Somerset West

  • Clinical Project Research

    Worcester

Other trials in South Africa

Sweden3 sites

  • Universitetssjukhuset Malmö

    Malmö

  • Universitetssjukhuset Örebro

    Örebro

  • Akademiska Sjukhuset

    Uppsala

Other trials in Sweden

Singapore1 site

  • National Heart Center

    Singapore

Other trials in Singapore

About this 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).

Being tested
Placebo, Vernakalant (oral)
Keywords
Atrial Fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

  • Vernakalant (oral)Drug

    Also called RSD1235-SR

    Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)

Study groups in NCT00526136
Study groupRoleWhat they receive
1Placebo comparatorPlacebo (b.i.d.)
Receives: Drug: Placebo
2ExperimentalVernakalant (oral), 150 mg (b.i.d.)
Receives: Drug: Vernakalant (oral)
3ExperimentalVernakalant (oral), 300 mg (b.i.d.)
Receives: Drug: Vernakalant (oral)
4ExperimentalVernakalant (oral), 500 mg (b.i.d.)
Receives: Drug: Vernakalant (oral)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first documented recurrence of symptomatic sustained AF.

    Measured: Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing

  2. Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events

    Measured: Safety assessments within Day 120 of dosing

Secondary outcomes (6)

  1. Time to first documented recurrence of symptomatic or asymptomatic sustained AF

    Measured: Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing

  2. Time to first documented recurrence of symptomatic AF

    Measured: Time to first documented recurrence of symptomatic AF within 90 days of dosing

  3. Time to first documented recurrence of symptomatic or asymptomatic AF

    Measured: Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing

  4. Proportion of subjects in sinus rhythm on Day 90.

    Measured: Proportion of subjects in sinus rhythm on Day 90 of dosing

  5. Improvement in AF symptoms as assessed by an AF symptom checklist.

    Measured: Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing

  6. Improvement in QOL as measured by SF-36

    Measured: Improvement in QOL as measured by SF-36 within Day 90 of dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study startMar 2007
  3. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
735 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00526136
Sponsor's protocol ID
1235-SR-202-AF
Status last verified
Dec 2008
First submitted
5 Sep 2007
Last updated
18 Dec 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21841207

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vernakalant (oral) in people with Atrial Fibrillation, run by Advanz Pharma at 152 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in Ukraine, Poland, Russia, Czechia, Hungary and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00526136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2008.

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