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)
Sponsor
Forest Laboratories (Industry)
Overall Status
Terminated
CT.gov ID
NCT01464476
Collaborator
(none)
240
138
2
19
1.7
0.1
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator
Study Start Date
:
Nov 1, 2011
Anticipated Primary Completion Date
:
May 1, 2013
Anticipated Study Completion Date
:
Jun 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Azimilide Azimilide 75 mg film coated tablets |
Drug: Azimilide Dihydrochloride
Azimilide 75 mg. Once daily, oral administration
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Dose-matched placebo. Once daily, oral administration
|
Outcome Measures
Primary Outcome Measures
- Time to first cardiovascular event [365 days]
Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)
Secondary Outcome Measures
- Time to first all-cause shock by the ICD [365 days]
Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator
- Time to first unplanned physician-office visit. [365 days]
Time to the first unplanned physician-office visit.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy.
-
Have a left ventricular ejection fraction <= 0.40
Exclusion Criteria:
-
Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization;
-
Have unstable angina pectoris or a myocardial infarction within 30 days of randomization;
-
Have a history of Torsade de Pointes or heart transplantation
-
Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening;
-
Are currently taking systemic Class I or other Class III antiarrhythmic drugs
-
Are currently taking systemic drugs that prolong the QT interval
-
If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Forest Investigative Site 053 | Birmingham | Alabama | United States | 35211 |
| 2 | Forest Investigative Site 048 | Huntsville | Alabama | United States | 35801 |
| 3 | Forest Investigative Site 013 | Phoenix | Arizona | United States | 85013 |
| 4 | Forest Investigative Site 110 | Los Angeles | California | United States | 99048 |
| 5 | Forest Investigative Site 022 | Merced | California | United States | 95340 |
| 6 | Forest Investigative Site 060 | Colorado Springs | Colorado | United States | 80909 |
| 7 | Forest Investigative Site 090 | Littleton | Colorado | United States | 80712 |
| 8 | Forest Investigative Site 041 | Newark | Delaware | United States | 19718 |
| 9 | Forest Investigative Site 113 | Hollywood | Florida | United States | 33021 |
| 10 | Forest Investigative Site 010 | Jacksonville | Florida | United States | 32204 |
| 11 | Forest Investigative Site 035 | Lakeland | Florida | United States | 33805 |
| 12 | Forest Investigative Site 044 | Port Charlotte | Florida | United States | 33952 |
| 13 | Forest Investigative Site 062 | Rockledge | Florida | United States | 32955 |
| 14 | Forest Investigative Site 082 | Safety Harbor | Florida | United States | 34695 |
| 15 | Forest Investigative Site 006 | Zephyrhills | Florida | United States | 33542 |
| 16 | Forest Investigative Site 123 | Augusta | Georgia | United States | 30901 |
| 17 | Forest Investigative Site 092 | Boise | Idaho | United States | 83712 |
| 18 | Forest Investigative Site 012 | Bloomington | Indiana | United States | 47402 |
| 19 | Forest Investigative Site 068 | Indianapolis | Indiana | United States | 46237 |
| 20 | Forest Investigative Site 087 | South Bend | Indiana | United States | 46601 |
| 21 | Forest Investigative Site 063 | Houma | Louisiana | United States | 70360 |
| 22 | Forest Investigative Site 050 | Auburn | Maine | United States | 04210 |
| 23 | Forest Investigative Site 030 | Baltimore | Maryland | United States | 21201 |
| 24 | Forest Investigative Site 058 | Baltimore | Maryland | United States | 21237 |
| 25 | Forest Investigative Site 052 | Lanham | Maryland | United States | 20706 |
| 26 | Forest Investigative Site 118 | Silver Spring | Maryland | United States | 20903 |
| 27 | Forest Investigative Site 015 | Boston | Massachusetts | United States | 02215 |
| 28 | Forest Investigative Site 091 | Brighton | Massachusetts | United States | 02135 |
| 29 | Forest Investigative Site 020 | Saginaw | Michigan | United States | 48601 |
| 30 | Forest Investigative Site 085 | Southfield | Michigan | United States | 48075 |
| 31 | Forest Investigative Site 079 | Troy | Michigan | United States | 48085 |
| 32 | Forest Investigative Site 034 | Ypsilanti | Michigan | United States | 48197 |
| 33 | Forest Investigative Site 121 | Tupelo | Mississippi | United States | 38801 |
| 34 | Forest Investigative Site 088 | St. Louis | Missouri | United States | 63110 |
| 35 | Forest Investigative Site 100 | St. Louis | Missouri | United States | 63125 |
| 36 | Forest Investigative Site 055 | Englewood, | New Jersey | United States | 07631 |
| 37 | Forest Investigative Site 059 | Ridgewood | New Jersey | United States | 07450 |
| 38 | Forest Investigative Site 106 | Warren | New Jersey | United States | 07059 |
| 39 | Forest Investigative Site 112 | Albuquerque | New Mexico | United States | 87102 |
| 40 | Forest Investigative Site 018 | Albany | New York | United States | 12205 |
| 41 | Forest Investigative Site 069 | Albany | New York | United States | 12211 |
| 42 | Forest Investigative Site 045 | New York | New York | United States | 10021 |
| 43 | Forest Investigative Site 122 | New York | New York | United States | 10032 |
| 44 | Forest Investigative Site 075 | Williamsville | New York | United States | 14221 |
| 45 | Forest Investigative Site 089 | Chapel Hill | North Carolina | United States | 27599 |
| 46 | Forest Investigative Site 116 | Greensboro | North Carolina | United States | 27401 |
| 47 | Forest Investigative Site 070 | Canton | Ohio | United States | 44708 |
| 48 | Forest Investigative Site 064 | Cincinnati | Ohio | United States | 45219 |
| 49 | Forest Investigative Site 124 | Cincinnati | Ohio | United States | 45242 |
| 50 | Forest Investigative Site 043 | Columbus | Ohio | United States | 43214 |
| 51 | Forest Investigative Site 083 | Kettering | Ohio | United States | 45429 |
| 52 | Forest Investigative Site 109 | Toledo | Ohio | United States | 43615 |
| 53 | Forest Investigative Site 119 | Oklahoma City | Oklahoma | United States | 73120 |
| 54 | Forest Investigative Site 003 | Tulsa | Oklahoma | United States | 74104 |
| 55 | Forest Investigative Site 056 | Camp Hill | Pennsylvania | United States | 17011 |
| 56 | Forest Investigative Site 081 | Erie | Pennsylvania | United States | 16502 |
| 57 | Forest Investigative Site 008 | Erie | Pennsylvania | United States | 16507 |
| 58 | Forest Investigative Site 024 | Hershey | Pennsylvania | United States | 17033 |
| 59 | Forest Investigative Site 095 | Philadelphia | Pennsylvania | United States | 19141 |
| 60 | Forest Investigative Site 005 | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 61 | Forest Investigative Site 107 | Yardley | Pennsylvania | United States | 19067 |
| 62 | Forest Investigative Site 046 | York | Pennsylvania | United States | 17403 |
| 63 | Forest Investigative Site 084 | Providence | Rhode Island | United States | 02903 |
| 64 | Forest Investigative Site 066 | Florence | South Carolina | United States | 29501 |
| 65 | Forest Investigative Site 073 | Greenville | South Carolina | United States | 29607 |
| 66 | Forest Investigative Site 014 | Rapid City | South Dakota | United States | 57701 |
| 67 | Forest Investigative Site 094 | Sioux Falls | South Dakota | United States | 57108 |
| 68 | Forest Investigative Site 029 | Corpus Christi | Texas | United States | 78404 |
| 69 | Forest Investigative Site 028 | Dallas | Texas | United States | 75390 |
| 70 | Forest Investigative Site 007 | Fort Worth, | Texas | United States | 76104 |
| 71 | Forest Investigative Site 111 | Fort Worth | Texas | United States | 76104 |
| 72 | Forest Investigative Site 125 | Houston | Texas | United States | 77030 |
| 73 | Forest Investigative Site 076 | Houston | Texas | United States | 77094 |
| 74 | Forest Investigative Site 074 | San Antonio | Texas | United States | 78229 |
| 75 | Forest Investigative Site 016 | Chesapeake | Virginia | United States | 23320 |
| 76 | Forest Investigative Site 004 | Falls Church | Virginia | United States | 22042 |
| 77 | Forest Investigative Site 117 | Lynchburg | Virginia | United States | 24501 |
| 78 | Forest Investigative Site 065 | Newport News | Virginia | United States | 23601 |
| 79 | Forest Investigative Site 072 | Richmond | Virginia | United States | 23219 |
| 80 | Forest Investigative Site 023 | Roanoke | Virginia | United States | 24104 |
| 81 | Forest Investigative Site 071 | Green Bay | Wisconsin | United States | 54301 |
| 82 | Forest Investigative Site 042 | Madison | Wisconsin | United States | 53715 |
| 83 | Forest Investigative Site 049 | Milwaukee | Wisconsin | United States | 53215 |
| 84 | Forest Investigative Site 302 | Brugge | Belgium | 8000 | |
| 85 | Forest Investigative Site 303 | Charleroi | Belgium | 6000 | |
| 86 | Forest Investigative Site 300 | Leuven | Belgium | 3000 | |
| 87 | Forest Investigative Site 304 | Liège | Belgium | 4000 | |
| 88 | Forest Investigative Site 301 | Yvoir | Belgium | 5530 | |
| 89 | Forest Investigative Site 264 | Edmonton | Alberta | Canada | T5H 3V9 |
| 90 | Forest Investigative Site 269 | Vancouver | British Columbia | Canada | V5Z1M9 |
| 91 | Forest Investigative Site 252 | Victoria | British Columbia | Canada | V8R 4R2 |
| 92 | Forest Investigative Site 267 | Hamilton | Ontario | Canada | L8L 2X2 |
| 93 | Forest Investigative Site 253 | Kingston | Ontario | Canada | K7L2V7 |
| 94 | Forest Investigative Site 259 | Toronto | Ontario | Canada | M4N 3M5 |
| 95 | Forest Investigative Site 263 | Toronto | Ontario | Canada | M5B 1N9 |
| 96 | Forest Investigative Site 254 | Montreal | Quebec | Canada | H2W 1T8 |
| 97 | Forest Investigative Site 250 | Montreal | Quebec | Canada | H3G1A4 |
| 98 | Forest Investigative Site 270 | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 99 | Forest Investigative Site 262 | Saskatoon | Saskatchewan | Canada | S7N 0W8 |
| 100 | Forest Investigative Site 750 | Brno | Czech Republic | 65691 | |
| 101 | Forest Investigative Site 753 | Ceské Budejovice | Czech Republic | 37001 | |
| 102 | Forest Investigative Site 751 | Olomouc | Czech Republic | 77520 | |
| 103 | Forest Investigative Site 754 | Prague | Czech Republic | 15030 | |
| 104 | Forest Investigative Site 752 | Sokolska | Czech Republic | 0581 | |
| 105 | Forest Investigative Site 852 | Aalborg | Denmark | DK-9100 | |
| 106 | Forest Investigative Site 850 | Copenhagen | Denmark | DK-2100 | |
| 107 | Forest Investigative Site 854 | Esbjerg | Denmark | DK6700 | |
| 108 | Forest Investigative Site 853 | Hellerup | Denmark | DK-2900 | |
| 109 | Forest Investigative Site 851 | Odense | Denmark | DK-5000 | |
| 110 | Forest Investigative Site 353 | Grenoble | France | 38043 | |
| 111 | Forest Investigative Site 354 | Lille | France | 59037 | |
| 112 | Forest Investigative Site 350 | Montpellier | France | 34295 | |
| 113 | Forest Investigative Site 358 | Nantes | France | 44800 | |
| 114 | Forest Investigative Site 357 | Pessac | France | 33604 | |
| 115 | Forest Investigative Site 405 | Berlin | Germany | 14050 | |
| 116 | Forest Investigative Site 402 | Gottingen | Germany | 37099 | |
| 117 | Forest Investigative Site 410 | Heidelberg | Germany | 69120 | |
| 118 | Forest Investigative Site 406 | Ludwigshafen | Germany | 67063 | |
| 119 | Forest Investigative Site 401 | Mannheim | Germany | D-68167 | |
| 120 | Forest Investigative Site 450 | Ashkelon | Israel | 78278 | |
| 121 | Forest Investigative Site 453 | Jerusalem | Israel | 91120 | |
| 122 | Forest Investigative Site 452 | Tel Aviv | Israel | 64239 | |
| 123 | Forest Investigative Site 451 | Tel Hashomer | Israel | 52621 | |
| 124 | Forest Investigative Site 504 | Ancona | Italy | 41060 | |
| 125 | Forest Investigative Site 502 | Catania | Italy | 95124 | |
| 126 | Forest Investigative Site 552 | Breda | Netherlands | 4818 CK | |
| 127 | Forest Investigative Site 550 | Eindhoven | Netherlands | 5623 | |
| 128 | Forest Investigative Site 555 | Zwolle | Netherlands | 8011 JW | |
| 129 | Forest Investigative Site 706 | Gdansk | Poland | 80-952 | |
| 130 | Forest Investigative Site 705 | Gdynia | Poland | 81-423 | |
| 131 | Forest Investigative Site 604 | Barcelona | Spain | 08036 | |
| 132 | Forest Investigative Site 601 | Malaga | Spain | 29010 | |
| 133 | Forest Investigative Site 800 | Lund | Sweden | 22185 | |
| 134 | Forest Investigative Site 805 | Orebro | Sweden | 70185 | |
| 135 | Forest Investigative Site 804 | Stockholm | Sweden | 11883 | |
| 136 | Forest Investigative Site 802 | Stockholm | Sweden | 17176 | |
| 137 | Forest Investigative Site 801 | Uppsala | Sweden | 75185 | |
| 138 | Forest Investigative Site 803 | Vasteras | Sweden | 72189 |
Sponsors and Collaborators
- Forest Laboratories
Investigators
- Study Director: David B Bharucha, MD, PhD, Forest Laboratories
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01464476
Other Study ID Numbers:
- AZM-MD-302
First Posted:
Nov 3, 2011
Last Update Posted:
May 6, 2013
Last Verified:
May 1, 2013
Additional relevant MeSH terms: