Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

PHASE3TerminatedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

June 30, 2013

Conditions
Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesImplantable Cardioverter Defibrillator
Interventions
DRUG

Azimilide Dihydrochloride

Azimilide 75 mg. Once daily, oral administration

DRUG

Placebo

Dose-matched placebo. Once daily, oral administration

Trial Locations (138)

3000

Forest Investigative Site 300, Leuven

4000

Forest Investigative Site 304, Liège

5530

Forest Investigative Site 301, Yvoir

5623

Forest Investigative Site 550, Eindhoven

6000

Forest Investigative Site 303, Charleroi

8000

Forest Investigative Site 302, Bruges

10021

Forest Investigative Site 045, New York

10032

Forest Investigative Site 122, New York

11883

Forest Investigative Site 804, Stockholm

12205

Forest Investigative Site 018, Albany

12211

Forest Investigative Site 069, Albany

14050

Forest Investigative Site 405, Berlin

14221

Forest Investigative Site 075, Williamsville

15030

Forest Investigative Site 754, Prague

16502

Forest Investigative Site 081, Erie

16507

Forest Investigative Site 008, Erie

17011

Forest Investigative Site 056, Camp Hill

17033

Forest Investigative Site 024, Hershey

17176

Forest Investigative Site 802, Stockholm

17403

Forest Investigative Site 046, York

18711

Forest Investigative Site 005, Wilkes-Barre

19067

Forest Investigative Site 107, Yardley

19141

Forest Investigative Site 095, Philadelphia

19718

Forest Investigative Site 041, Newark

20706

Forest Investigative Site 052, Lanham

20903

Forest Investigative Site 118, Silver Spring

21201

Forest Investigative Site 030, Baltimore

21237

Forest Investigative Site 058, Baltimore

22042

Forest Investigative Site 004, Falls Church

22185

Forest Investigative Site 800, Lund

23219

Forest Investigative Site 072, Richmond

23320

Forest Investigative Site 016, Chesapeake

23601

Forest Investigative Site 065, Newport News

24104

Forest Investigative Site 023, Roanoke

24501

Forest Investigative Site 117, Lynchburg

27401

Forest Investigative Site 116, Greensboro

27599

Forest Investigative Site 089, Chapel Hill

29010

Forest Investigative Site 601, Málaga

29501

Forest Investigative Site 066, Florence

29607

Forest Investigative Site 073, Greenville

30901

Forest Investigative Site 123, Augusta

32204

Forest Investigative Site 010, Jacksonville

32955

Forest Investigative Site 062, Rockledge

33021

Forest Investigative Site 113, Hollywood

33542

Forest Investigative Site 006, Zephyrhills

33604

Forest Investigative Site 357, Pessac

33805

Forest Investigative Site 035, Lakeland

33952

Forest Investigative Site 044, Port Charlotte

34295

Forest Investigative Site 350, Montpellier

34695

Forest Investigative Site 082, Safety Harbor

35211

Forest Investigative Site 053, Birmingham

35801

Forest Investigative Site 048, Huntsville

37001

Forest Investigative Site 753, České Budějovice

37099

Forest Investigative Site 402, Göttingen

38043

Forest Investigative Site 353, Grenoble

38801

Forest Investigative Site 121, Tupelo

41060

Forest Investigative Site 504, Ancona

43214

Forest Investigative Site 043, Columbus

43615

Forest Investigative Site 109, Toledo

44708

Forest Investigative Site 070, Canton

44800

Forest Investigative Site 358, Nantes

45219

Forest Investigative Site 064, Cincinnati

45242

Forest Investigative Site 124, Cincinnati

45429

Forest Investigative Site 083, Kettering

46237

Forest Investigative Site 068, Indianapolis

46601

Forest Investigative Site 087, South Bend

47402

Forest Investigative Site 012, Bloomington

48075

Forest Investigative Site 085, Southfield

48085

Forest Investigative Site 079, Troy

48197

Forest Investigative Site 034, Ypsilanti

48601

Forest Investigative Site 020, Saginaw

52621

Forest Investigative Site 451, Tel Litwinsky

53215

Forest Investigative Site 049, Milwaukee

53715

Forest Investigative Site 042, Madison

54301

Forest Investigative Site 071, Green Bay

57108

Forest Investigative Site 094, Sioux Falls

57701

Forest Investigative Site 014, Rapid City

59037

Forest Investigative Site 354, Lille

63110

Forest Investigative Site 088, St Louis

63125

Forest Investigative Site 100, St Louis

64239

Forest Investigative Site 452, Tel Aviv

65691

Forest Investigative Site 750, Brno

67063

Forest Investigative Site 406, Ludwigshafen

69120

Forest Investigative Site 410, Heidelberg

70185

Forest Investigative Site 805, Örebro

70360

Forest Investigative Site 063, Houma

72189

Forest Investigative Site 803, Västerås

73120

Forest Investigative Site 119, Oklahoma City

74104

Forest Investigative Site 003, Tulsa

75185

Forest Investigative Site 801, Uppsala

75390

Forest Investigative Site 028, Dallas

76104

Forest Investigative Site 007, Fort Worth

Forest Investigative Site 111, Fort Worth

77030

Forest Investigative Site 125, Houston

77094

Forest Investigative Site 076, Houston

77520

Forest Investigative Site 751, Olomouc

78229

Forest Investigative Site 074, San Antonio

78278

Forest Investigative Site 450, Ashkelon

78404

Forest Investigative Site 029, Corpus Christi

80712

Forest Investigative Site 090, Littleton

80909

Forest Investigative Site 060, Colorado Springs

83712

Forest Investigative Site 092, Boise

85013

Forest Investigative Site 013, Phoenix

87102

Forest Investigative Site 112, Albuquerque

91120

Forest Investigative Site 453, Jerusalem

95124

Forest Investigative Site 502, Catania

95340

Forest Investigative Site 022, Merced

99048

Forest Investigative Site 110, Los Angeles

04210

Forest Investigative Site 050, Auburn

02215

Forest Investigative Site 015, Boston

02135

Forest Investigative Site 091, Brighton

07631

Forest Investigative Site 055, Englewood

07450

Forest Investigative Site 059, Ridgewood

07059

Forest Investigative Site 106, Warren Township

02903

Forest Investigative Site 084, Providence

T5H 3V9

Forest Investigative Site 264, Edmonton

V5Z1M9

Forest Investigative Site 269, Vancouver

V8R 4R2

Forest Investigative Site 252, Victoria

L8L 2X2

Forest Investigative Site 267, Hamilton

K7L2V7

Forest Investigative Site 253, Kingston

M4N 3M5

Forest Investigative Site 259, Toronto

M5B 1N9

Forest Investigative Site 263, Toronto

H2W 1T8

Forest Investigative Site 254, Montreal

H3G1A4

Forest Investigative Site 250, Montreal

J1H 5N4

Forest Investigative Site 270, Sherbrooke

S7N 0W8

Forest Investigative Site 262, Saskatoon

0581

Forest Investigative Site 752, Sokolska

DK-9100

Forest Investigative Site 852, Aalborg

DK-2100

Forest Investigative Site 850, Copenhagen

DK6700

Forest Investigative Site 854, Esbjerg

DK-2900

Forest Investigative Site 853, Hellerup

DK-5000

Forest Investigative Site 851, Odense

D-68167

Forest Investigative Site 401, Mannheim

4818 CK

Forest Investigative Site 552, Breda

8011 JW

Forest Investigative Site 555, Zwolle

80-952

Forest Investigative Site 706, Gdansk

81-423

Forest Investigative Site 705, Gdynia

08036

Forest Investigative Site 604, Barcelona

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY