AzTrials
AzTrials

Atrial FibrillationPhase 3NCT00035451

Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

A Phase 3 study testing Azimilide Dihydrochloride and Sotalol in people with Atrial Fibrillation, run by Forest Laboratories at 129 sites in 9 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

Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Azimilide Dihydrochloride and Sotalol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
658 participants
Where
129 sitesin 9 countries
Study dates
Feb 2001to Jun 2003
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening
  • Require the procedure of cardioversion (electric shock to correct abnormal rhythm)
  • In the investigator's opinion, is likely to maintain sinus rhythm after cardioversion.
  • Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines.

Who cannot join

  • Previously unsuccessful electrical cardioversions
  • Failed to respond to any Class III antiarrhythmic drugs
  • Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization

Trial locations and contacts

129 sites in 9 countries.

129 sites in 9 countries

Germany24 sites

  • Erzgebirgskrankenhaus Klinik fur Innere Medizin

    Annaberg, 09456

  • Kerckhhoff-Klinik Abteilung Klinische Pharmakologie

    Bad Nauheim, 61231

  • Kardiologie Herzzentrum Osnabruck

    Bad Rothenfelde, 49214

  • Dr. Schreiber Krankenhaus Neukoelin 1 Innere Rudowerstrasse, 48

    Berlin, 12351

  • Franz-Volhard-Klinik Abteilung fur Elektrophysiologie

    Berlin, 13125

  • Stadisches Klinikum Brandenburg Med-Klinik I/Kardiologie Pulmologie und Angiologie

    Brandenburg, 14770

  • Klinikum Coburg II Med. Klinik

    Coburg, 96450

  • Klinkum Lippe-Detmold Med. Klink II-Kardiologie

    Detmold, 32756

  • Krankenhaus Duren Medizinische Klinik I Kardiologie/Angiologie

    Düren, 52351

  • Klinikum Erfurt GmbH

    Erfurt, 99012

  • Medizinische Universitaetsklinik Innere Medizin III Kardiologie und Angiologie

    Frieburg, 79016

  • Universitatsklinikum Hamburg-Eppendork Klinik und Poliklinik fur Innere Medizin Abteilung Kardiologie

    Hamburg, 20246

  • Medizinische Hochschule Innere Medizin/Abt. fur Kardiologie

    Hanover, 30625

  • Universitatsklinikum Heidelberg

    Heidelberg, 69115

  • Medizinische Universitats-und Ploiklinik Innere Medizin 3

    Homburg, 66421

  • Klinikum Kassel Medizinische Klinik II

    Kassel, 34125

  • Universitate zu Koeln Klinik III fur Innere Medizin

    Koeln (Lindenthal), 50924

  • Universitat Leipzig Medizinische Klinik und Poliklinik 1 Abteilung fur Kardiologie and Angiolgie

    Leipzig, 04103

  • Klinikum der Stadt Ludwigshafen Abteilung fur Elektrophysiologie der Kardiologie/Herzzentrum

    Ludwigshafen, 67063

  • Medizinische Klinik und Poliklnik Innere Medizin C

    Mannheim, 68167

  • Medizinische Klinik und Poliklinik Innere Medizin C

    Münster, D-48149

  • Klinik am See REHA-Zentrum fur Herz und Kreislauf

    Rüdersdorf, 15562

  • Medizinische Universitat Tubingen Med. Klinik III, Abt. III fur Kardiologie

    Tübingen, 72076

  • Reinhard-Nieter-Krankenhaus Med. Klinik 1

    Wilhelmshafen, 26389

Other trials in Germany

Poland20 sites

  • Samodzielny Publiczny Szpital Kliniczny Klinika Kardiologii

    Bialystok, 15-276

  • I Klinika Chorob Serca Instytut Kardiologii AM

    Gdansk, 80-211

  • Gornoslaskie Centrum Medyczne I Klinika Kardiologii

    Katowice, 40-635

  • Szpital Wojewodzki Oddzial Kardiologii

    Kielce, 25-736

  • Instytut Kardiologii CMUJ Klinika Choroby Wiencowej

    Krakow, 31-202

  • Oddzial Kardilolgii Wojewodski Szpital Specjalistyczny

    Olsztyn, 10-561

  • Oddzial Kardiologii Wojewodzkie Centrum Medyczne

    Opole, 45-418

  • Oddizial Wewnetzny Szpital Miejski

    Ostrowiec Świętokrzyski, 27-400

  • Oddzial Kardiologii Wojewodzki Szpital Zespolony

    Płock, 09-400

  • Radomski Szpital Specjalistyczny Oddzial Kardiologii

    Radom, 26-600

  • Oddizial Kardiologii Szpital Wojewodzki nr 2

    Rzeszów, 35-301

  • Samodzielny Publiczny Szpital Zespolony Oddizial Kardiologii

    Szczecin, 71-455

  • Wojewodzki Szpital Zespolony Oddzial Kardilolgii

    Torun, 87-100

  • Klinika Gastroenterologii i Chorob Wewnetrznych Szpital Wojewodzki Zespolony im. Biziela

    Ul Ujejskiego 75, Bydgoszcz, 85-168

  • Oddizial Kardiologii Wojewodzki Szpital Zespolony

    Ul Ujejskiego 75, Bydgoszcz, 85-168

  • I Klinika Kardiologii CSK WAM

    Warsaw, 00-909

  • Szpital Wolski im. Dr Anny Gostynskiej Oddzial Kardiologii

    Warsaw, 02-211

  • Instytut Kardiologii

    Warsaw, 04-268

  • Klinika Kardiologii IV Wojskowy Szpital Kliniczny

    Wroclaw, 50-981

  • Oddzial Kardiologii Szpital Wojewodzki

    Zamość, 22-400

Other trials in Poland

Russia20 sites

  • Cardiology Department, Moscow Clinical Hospital No. 59

    Moscow, 103030

  • Res. Inst. of Physical and Chemical Medicine Department of Cardiology Moscow Clinical Hospital No. 29

    Moscow, 111020

  • Russian State Medical University Clinical facility: Cardiology Department of City Clinical Hospital No. 4

    Moscow, 113096

  • Moscow State Institute of Peace and Friendship Pharmacology Department, Moscow Clinical Hospital #64

    Moscow, 117292

  • Cardiology Department Moscow Sechenov Medical Academy

    Moscow, 119881

  • Medical Centre of General Management Department of the President of the Russian Federation, Cardiology Department Moscow Clinical Hospital No. 51

    Moscow, 121309

  • Medical Centre of General Management Department of the President of the Russian Federation

    Moscow, 121356

  • Cardiology Department of State Medical Academy of Postgraduate Education, Myasnikov Clinical Cardiology Research Institute

    Moscow, 121552

  • Department of Emergency Cardiology Russian Cardiology Research Centre

    Moscow, 121552

  • Moscow State University of Medicine and Stomatolog, Cardiology Department of Moscow Clinical Hospital No. 50

    Moscow, 125206

  • Department of Internal Disease No. 5, Moscow State University of Medicine and Stomatology, Cardiology Department Moscow City Hospital No. 11

    Moscow, 127018

  • Myocardial Infarction Department St Petersburg Hospital, No. 28

    Saint Petersburg, 190000

  • Cardiology Department, State Research Institute

    Saint Petersburg, 192242

  • Cardiology Department Alexandrovskiy Hospital

    Saint Petersburg, 193318

  • Cardiology Department St Petersburg Hospital No. 2

    Saint Petersburg, 194354

  • Myocardial Infarction Department St Elizabeth Hospital

    Saint Petersburg, 195257

  • Cardiology Department St. Petersburg State Pavlov Medical University

    Saint Petersburg, 197022

  • Myocardial Infarction Department St Petersburg Hodpital, No. 29

    Saint Petersburg, 197022

  • Cardiology Department, St Petersburg Hospital, No. 15

    Saint Petersburg, 198205

  • Department of Cardiology No. 3 Pokrovskiy Hospital

    Saint Petersburg, 199106

Other trials in Russia

Hungary18 sites

  • State Hospital

    Balatonfüred, 8230

  • Gottsegen Gyorgy National Institute of Cardiology

    Budapest, 1096

  • Szent Imre Hospital, Dept. of Internal MedicineI.

    Budapest, 1115

  • Semmelweis University, Dept. of Internal Medicine III.

    Budapest, 1125

  • National Institiute of Pulmonology, Dept. of Cardiology

    Budapest, 1529

  • Toldi Ferenc Hospital, Dept. of Internal Medicine II.

    Cegléd, 2700

  • Debrecen City Health Service

    Debrecen, 4032

  • Markoth Ferenc County Hospital

    Eger, 3301

  • Pandy Kalman Hospital

    Gyula, 5700

  • County Hospital, Dept. of Internal Medicine I.

    Kecskemét, 6000

  • Miskolc County Hospital

    Miskolc, 3562

  • Mosonmagyarovar City Karolina Hospital

    Mosonmagyaróvár, 9200

  • University of Pecs, Cardiology Clinic

    Pécs, 7621

  • Siofok City Hospital

    Siófok, 8601

  • Allami Szanatorium

    Sopron, 9400

  • Szent Gyorgy Hospital

    Székesfehérvár, 8000

  • County Hospital, Dept. of Internal Medicine

    Szentes, 6601

  • Markusovszky Hospital, Dept. of Internal Medicine III.

    Szombathely, 9700

Other trials in Hungary

France15 sites

  • Service de Cardilolgie CH du Pays d'Aix

    Aix-en-Provence, 13616

  • CHR Besancon Service de cardiologie

    Besançon, 25030

  • Hopital Gavriel Montpied Cardiologie-Maladie cardiovascularies

    Clermont-Ferrand, 63000

  • Service de Cardiologie CHRU

    Grenoble, 38046

  • Cardiologie Hopital Jean Rostand

    Ivry-sur-Seine, 94205

  • Service de Cardiologie A Hopital Cardiologique

    Lille, 59037

  • Service de Cardiologie Hopital Saint Philibert

    Lomme, 59160

  • Cardilolgie Hopital Guillaume et Rene Laennec

    Nantes, 44093

  • Service de Cardiologie Hopital Lariboisiere

    Paris, 75010

  • Service de Cardiologie et Maladies Vascularies CHRU Pontchaillou

    Rennes, 35000

  • Cardiologie CHRU St Etienne/Hopital Nord

    Saint-Etienne, 42055

  • Centre Hospitalier General Hospital De Girac

    Saint-Michel-sur-Orge, 16470

  • Cardiologie/Pavillon Baudot Centre Hospitalier Universitaire Purpan

    Toulouse, 31059

  • Cardiologie A CHU Rangueil

    Toulouse, 31403

  • Service de cardiologie Hopitaux de Brabois/CHRU Nancy

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy13 sites

  • Divisione di Cardiologia Ospedale Civile

    Asti, 14100

  • Cardiovascular Disease Unit University of Bari-Ploiclinico

    Bari, 70124

  • Azienda Ospedaliera "Garibaldi S, Luigi Ascoli Tomaselli" Servizio di Cardiologia

    Catania, 95100

  • Servizio di Cardiologia Azienda Ospedaliera S. Anna

    Como, 22100

  • Cardiology Division Hospital "Santa Croce e Carle"

    Cuneo, 12100

  • Department of Internal Medicine (DIMI) University of Genova

    Genova, 16132

  • Ospedale Civile Umberto I Cardiology Division

    Mestre, 30170

  • S. Paolo Hospital University of Milan Department of Cardiology

    Milan, 20142

  • Cardiology Unit University of Naples "Frederico II"

    Naples, 80131

  • Cardiology Unit Policlinico S. Matteo

    Pavia, 27100

  • Osp. Civile di Piacenza-Div. di Cardiologia

    Piacenza, 29100

  • Dep. of Cardiovascular and Respiratory Diseases Policlinico Umberto I

    Roma, 00161

  • Ospedale Umberto I di Torino

    Torino, 10128

Other trials in Italy

Spain10 sites

  • Hospital Universitari San Juan Servicio di Cardiologia

    Alicante, 03550

  • Hospital Valle de Hebron Servicio de Cardiologia

    Barcelona, 08035

  • Hospital Princeps d'Espanya (Bellvitge) Servicio de cardiologia

    Barcelona, 08907

  • Hospital Civil De Basurto Cardiology Service

    Basurto-Bilbao, 48013

  • Hospital Nuestra Senora de Alarcos Unidad de Medicina Intensiva

    Ciudad Real, 13002

  • Hospital Universitario De Getafe Cardiology Service

    Getafe, 28905

  • Fundacion Jimenez Diaz Cardiology Service

    Madrid, 28040

  • Hospital Clinico Universitario San Carlos Servicio de Cardiologia

    Madrid, 28040

  • Hospital La Paz U.M.Q. de cardiologia

    Madrid, 28046

  • Hospital de Txagorritxu

    Vitoria-Gasteiz, 01009

Other trials in Spain

Netherlands6 sites

  • Catharina Ziekenhuis Afd. Cardilolgie

    Eindhoven, 5623

  • Kennemer Gasthuis

    Haarlem, 2035

  • Isala Klinieken Locatie De Weezenlanden

    JW Zwolle, 8011

  • Academisch Ziekenhuis Maastricht Afdeling Cardiologie

    Maastricht, 6229

  • Department Cardiology Canisius Wilhelmina Hospital

    Nijmegen, 6532

  • St Elisabeth Ziekenhuis Afdeling Cardiologie

    Tilburg, 5022

Other trials in Netherlands

Belgium3 sites

  • Clinique Generale Saint Jean Service de cardiologie

    Brussels, 1000

  • Hospital Universitarie Erasme

    Brussels, 1000

  • Cliniques Univeristaires UCL Mont-Godinne Avenue Theresse 1

    Yvoir, 5530

Other trials in Belgium

About this study

Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.

The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

Being tested
Azimilide Dihydrochloride, Placebo, Sotalol
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • Azimilide DihydrochlorideDrug

    125 mg azimilide tablets, twice a day for 6 months

  • PlaceboDrug

    tablets, twice daily for 6 months

  • SotalolDrug

    160 mg sot twice daily for 6 months

Study groups in NCT00035451
Study groupRoleWhat they receive
1Placebo comparatorplacebo tablets
Receives: Drug: Placebo
2Active comparatorSotalol
Receives: Drug: Sotalol
3Experimentalazimilide
Receives: Drug: Azimilide Dihydrochloride

What is being measured

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

  1. To prolong the time to first symptomatic or asymptomatic AFIB, etc event

    Measured: 6 month

Timeline

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

  1. First posted6 May 2002 (estimated)
  2. Study startFeb 2001
  3. Primary completionJun 2003
  4. Study completionJun 2003

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
658 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00035451
Sponsor's protocol ID
1999105
Status last verified
Sep 2011
First submitted
3 May 2002
Last updated
3 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azimilide Dihydrochloride and Sotalol in people with Atrial Fibrillation, run by Forest Laboratories at 129 sites in 9 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 4 inclusion and 3 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 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in Germany, Poland, Russia, Hungary, France and 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

To prolong the time to first symptomatic or asymptomatic AFIB, etc event (time frame: 6 month). 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 NCT00035451.

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 3 Oct 2011.

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