Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

PHASE2CompletedINTERVENTIONAL
Enrollment

486

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Arrhythmia ProphylaxisVentricular Arrhythmia
Interventions
DRUG

Celivarone

"Pharmaceutical form: capsule~Route of administration: oral"

DRUG

Amiodarone

"Pharmaceutical form: capsule~Route of administration: oral"

DRUG

Matching placebo

"Pharmaceutical form: capsule~Route of administration: oral~Matching placebo added to active drug if any for a total of 3 capsules per intake"

Trial Locations (151)

181

Investigational Site Number 710002, Pretoria

1027

Investigational Site Number 348004, Budapest

1090

Investigational Site Number 056001, Brussels

1428

Investigational Site Number 032002, Ciudad Autonoma de Bs.As

2050

Investigational Site Number 036014, Camperdown

2100

Investigational Site Number 208005, København Ø

2250

Investigational Site Number 036010, Gosford

2305

Investigational Site Number 036009, New Lambton

2605

Investigational Site Number 036013, Garran

2900

Investigational Site Number 208004, Hellerup

3004

Investigational Site Number 578003, Drammen

3400

Investigational Site Number 032003, Corrientes

3500

Investigational Site Number 056004, Hasselt

4029

Investigational Site Number 036005, Herston

4066

Investigational Site Number 036006, Auchenflower

4102

Investigational Site Number 036003, Woolloongabba

5000

Investigational Site Number 036012, Adelaide

Investigational Site Number 208001, Odense C

5042

Investigational Site Number 036004, Bedford Park

6000

Investigational Site Number 036007, Perth

6009

Investigational Site Number 036008, Nedlands

6060

Investigational Site Number 056002, Gilly

7624

Investigational Site Number 348005, Pécs

8000

Investigational Site Number 056007, Bruges

8200

Investigational Site Number 208002, Aarhus

8230

Investigational Site Number 348001, Balatonfüred

8800

Investigational Site Number 056003, Roeselare

8900

Investigational Site Number 348003, Zalaegerszeg

9300

Investigational Site Number 056005, Aalst

10001

Investigational Site Number 840031, New York

14080

Investigational Site Number 484002, Mexico City

15030

Investigational Site Number 203006, Prague

15706

Investigational Site Number 724006, Santiago de Compostela

16321

Investigational Site Number 276002, Bernau

17011

Investigational Site Number 840024, Camp Hill

18101

Investigational Site Number 376002, Afula

18901

Investigational Site Number 840030, Doylestown

19013

Investigational Site Number 840034, Upland

20246

Investigational Site Number 276006, Hamburg

22100

Investigational Site Number 380002, Como

23225

Investigational Site Number 840038, Richmond

23320

Investigational Site Number 840025, Chesapeake

23507

Investigational Site Number 840012, Norfolk

24125

Investigational Site Number 380008, Bergamo

28035

Investigational Site Number 724004, Madrid

28046

Investigational Site Number 724003, Madrid

29406

Investigational Site Number 840020, Charleston

29609

Investigational Site Number 250004, Brest

30901

Investigational Site Number 840004, Augusta

31048

Investigational Site Number 376004, Haifa

32806

Investigational Site Number 840010, Orlando

33520

Investigational Site Number 246004, Tampere

33707

Investigational Site Number 840013, St. Petersburg

Investigational Site Number 840043, St. Petersburg

33908

Investigational Site Number 840002, Fort Myers

34295

Investigational Site Number 250002, Montpellier

34304

Investigational Site Number 792003, Istanbul

34390

Investigational Site Number 792002, Istanbul

35033

Investigational Site Number 250007, Rennes

35801

Investigational Site Number 840006, Huntsville

36608

Investigational Site Number 840042, Mobile

37087

Investigational Site Number 203002, České Budějovice

37388

Investigational Site Number 840011, Tullahoma

38043

Investigational Site Number 250006, Grenoble

41008

Investigational Site Number 724009, Seville

46026

Investigational Site Number 724007, Valencia

46063

Investigational Site Number 203001, Liberec

48197

Investigational Site Number 840015, Ypsilanti

48236

Investigational Site Number 840026, Detroit

49770

Investigational Site Number 840003, Petoskey

50005

Investigational Site Number 203005, Hradec Králové

50141

Investigational Site Number 380001, Florence

54511

Investigational Site Number 250003, Vandœuvre-lès-Nancy

57701

Investigational Site Number 840048, Rapid City

59037

Investigational Site Number 250005, Lille

60148

Investigational Site Number 840035, Lombard

60590

Investigational Site Number 276001, Frankfurt am Main

60637

Investigational Site Number 840045, Chicago

64114

Investigational Site Number 840019, Kansas City

64239

Investigational Site Number 376001, Tel Aviv

65201

Investigational Site Number 840049, Columbia

65691

Investigational Site Number 203004, Brno

66160

Investigational Site Number 840017, Kansas City

70124

Investigational Site Number 380004, Bari

74104

Investigational Site Number 840029, Tulsa

75908

Investigational Site Number 250001, Paris

77520

Investigational Site Number 203003, Olomouc

78278

Investigational Site Number 376003, Ashkelon

80909

Investigational Site Number 840039, Colorado Springs

81104

Investigational Site Number 703001, Bratislava

85006

Investigational Site Number 840032, Phoenix

85206

Investigational Site Number 840014, Mesa

85723

Investigational Site Number 840033, Tucson

90277

Investigational Site Number 840054, Redondo Beach

94062

Investigational Site Number 840007, Redwood City

97616

Investigational Site Number 276005, Bad Neustadt an der Saale

99204

Investigational Site Number 840016, Spokane

197110

Investigational Site Number 643003, Saint Petersburg

199106

Investigational Site Number 643011, Saint Petersburg

443070

Investigational Site Number 643008, Samara

620102

Investigational Site Number 643006, Yekaterinburg

625023

Investigational Site Number 643007, Tyumen

634012

Investigational Site Number 643004, Tomsk

650002

Investigational Site Number 643005, Moscow

8380456

Investigational Site Number 152001, Santiago

33952-8008

Investigational Site Number 840005, Port Charlotte

04074

Investigational Site Number 840022, Scarborough

48109-0759

Investigational Site Number 840009, Ann Arbor

97201-3098

Investigational Site Number 840037, Portland

T4000NIL

Investigational Site Number 032004, San Miguel de Tucumán

T2N 2T9

Investigational Site Number 124009, Calgary

L8L 2X2

Investigational Site Number 124010, Hamilton

N6A 5A5

Investigational Site Number 124004, London

H1T 1C8

Investigational Site Number 124008, Montreal

H2W 1T8

Investigational Site Number 124001, Montreal

G1V 4G5

Investigational Site Number 124005, Ste-Foy

M5B 1W8

Investigational Site Number 124002, Toronto

V6E 1M9

Investigational Site Number 124006, Vancouver

V8R 4R2

Investigational Site Number 124007, Victoria

00290

Investigational Site Number 246001, Helsinki

01099

Investigational Site Number 276003, Dresden

00169

Investigational Site Number 380007, Roma

Unknown

Investigational Site Number 392004, Meguro-Ku

Investigational Site Number 392005, Niigata

Investigational Site Number 392006, Osaka

Investigational Site Number 392001, Osaka Sayama-Shi

Investigational Site Number 392003, Shinjuku-Ku

Investigational Site Number 392002, Suita-Shi

1815 JD

Investigational Site Number 528001, Alkmaar

1091 AC

Investigational Site Number 528005, Amsterdam

4818 CK

Investigational Site Number 528002, Breda

6229 HX

Investigational Site Number 528003, Maastricht

3015 CE

Investigational Site Number 528007, Rotterdam

8011 JW

Investigational Site Number 528004, Zwolle

85-094

Investigational Site Number 616007, Bydgoszcz

81-348

Investigational Site Number 616011, Gdynia

90-548

Investigational Site Number 616006, Lodz

91-425

Investigational Site Number 616003, Lodz

70-111

Investigational Site Number 616002, Szczecin

02-097

Investigational Site Number 616008, Warsaw

04-073

Investigational Site Number 616001, Warsaw

3000-075

Investigational Site Number 620004, Coimbra

1169-024

Investigational Site Number 620003, Lisbon

4430-502

Investigational Site Number 620005, Vila Nova de Gaia

04011

Investigational Site Number 703002, Košice

08036

Investigational Site Number 724001, Barcelona

08907

Investigational Site Number 724002, Barcelona

118 83

Investigational Site Number 752002, Stockholm

901 85

Investigational Site Number 752003, Umeå

751 85

Investigational Site Number 752001, Uppsala

06490

Investigational Site Number 792001, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY