Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)
Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00751738
Collaborator
(none)
330
86
1
36
3.8
0.1
Study Details
Study Description
Brief Summary
This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
330 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator
Study Start Date
:
Oct 1, 2002
Actual Primary Completion Date
:
Oct 1, 2005
Actual Study Completion Date
:
Oct 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 125 mg azimilide |
Drug: azimilide dihydrochloride
oral, once daily until sponsor stopped the study
|
Outcome Measures
Primary Outcome Measures
- safety of azimilide in this patient population [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- patients who completed at least 12 months on study 2000098 before inclusion in this study
Exclusion Criteria:
-
breast feeding or plan to become pregnant
-
used ticlopidine
-
were taking Class I or other Class III drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Facility | Mobile | Alabama | United States | 36608 |
| 2 | Research Facility | Little Rock | Arkansas | United States | 72205 |
| 3 | Research Facility | LaJolla | California | United States | 92037 |
| 4 | Research Facility | Loma Linda | California | United States | 932354 |
| 5 | Research Facility | Sacramento | California | United States | 95819 |
| 6 | Research Facility | Colorado Springs | Colorado | United States | 80910 |
| 7 | Research Facility | Bridgeport | Connecticut | United States | 06610 |
| 8 | Research Facility | Washington | District of Columbia | United States | 20010 |
| 9 | Research Facility | Ft. Lauderdale | Florida | United States | 33308 |
| 10 | Research Facility | Ft. Myers | Florida | United States | 33919 |
| 11 | Research Facility | Jacksonville | Florida | United States | 32207 |
| 12 | Research Facility | Maywood | Illinois | United States | 60153 |
| 13 | Research Facility | Kansas City | Kansas | United States | 66160 |
| 14 | Research Facility | Portland | Maine | United States | 04102 |
| 15 | Research Facility | Baltimore | Maryland | United States | 21201 |
| 16 | Research Facility | Baltimore | Maryland | United States | 21204 |
| 17 | Research Facility | Boston | Massachusetts | United States | 02135 |
| 18 | Research Facility | Burlington | Massachusetts | United States | 01805 |
| 19 | Research Facility | Worcester | Massachusetts | United States | 01655 |
| 20 | Research Facility | Warren | New Jersey | United States | 07059 |
| 21 | Research Facility | Brooklyn | New York | United States | 11212 |
| 22 | Research Facility | Johnson City | New York | United States | 13797 |
| 23 | Research Facility | New York | New York | United States | 10025 |
| 24 | Research Facility | New York | New York | United States | 10029 |
| 25 | Research Facility | Rochester | New York | United States | 14621 |
| 26 | Research Facility | Rochester | New York | United States | 14642 |
| 27 | Research Facility | West Orange | New York | United States | 07052 |
| 28 | Research Facility | Williamsville | New York | United States | 14221 |
| 29 | Research Site | Durham | North Carolina | United States | 27710 |
| 30 | Research Facility | Winston-Salem | North Carolina | United States | 27157 |
| 31 | Research Facility | Cincinnati | Ohio | United States | 45219 |
| 32 | Research Facility | Toledo | Ohio | United States | 43614 |
| 33 | Research Facility | Tulsa | Oklahoma | United States | 74104 |
| 34 | Research Facility | Erie | Pennsylvania | United States | 16502 |
| 35 | Research Facility | Hershey | Pennsylvania | United States | 17033 |
| 36 | Research Facility | Lancaster | Pennsylvania | United States | 17603 |
| 37 | Research Facility | Philadelphia | Pennsylvania | United States | 19104 |
| 38 | Research Facility | Charleston | South Carolina | United States | 29425 |
| 39 | Research Site | Columbia | South Carolina | United States | 29204 |
| 40 | Research Facility | Germantown | Tennessee | United States | 38138 |
| 41 | Research Facility | Nashville | Tennessee | United States | 37203 |
| 42 | Research Facility | Dallas | Texas | United States | 75226 |
| 43 | Research Facility | Dallas | Texas | United States | 75390 |
| 44 | Research Facility | Houston | Texas | United States | 77030 |
| 45 | Research Facility | Salt Lake City | Utah | United States | 84132 |
| 46 | Research Facility | Charlottesville | Virginia | United States | 22908 |
| 47 | Research Facility | Fairfax | Virginia | United States | 22031 |
| 48 | Research Facility | Spokane | Washington | United States | 99204 |
| 49 | Research Facility | Green Bay | Wisconsin | United States | 54301 |
| 50 | Research Facility | Milwaukee | Wisconsin | United States | 53215 |
| 51 | Research Facility | Brugge | Belgium | ||
| 52 | Research Facility | Mont Godinne | Belgium | ||
| 53 | Research Facility | Victoria | British Columbia | Canada | |
| 54 | Research Facility | St. Johns | Newfoundland and Labrador | Canada | |
| 55 | Research Site | Halifax | Nova Scotia | Canada | |
| 56 | Research Facility | Hamilton | Ontario | Canada | |
| 57 | Research Facility | Ottawa | Ontario | Canada | |
| 58 | Research Facility | Toronto | Ontario | Canada | |
| 59 | Research Facility | Montreal | Quebec | Canada | |
| 60 | Research Facility | Quebec | Canada | ||
| 61 | Research Facility | Lille Cedex | France | ||
| 62 | Research Facility | Nantes Cedex | France | ||
| 63 | Research Facility | Paris Cedex | France | ||
| 64 | Research Facility | Pessac Cedex | France | ||
| 65 | Research Facility | Tours Cedex | France | ||
| 66 | Research Facility | Bad Bevensen | Germany | ||
| 67 | Research Facility | Berlin | Germany | ||
| 68 | Research Facility | Brandenburg an der Havel | Germany | ||
| 69 | Research Facility | Coburg | Germany | ||
| 70 | Research Facility | Frankfurt | Germany | ||
| 71 | Research Facility | Freiburg | Germany | ||
| 72 | Research Facility | Hamburg | Germany | ||
| 73 | Research Facility | Heidelberg | Germany | ||
| 74 | Research Facility | Ludwigshafen | Germany | ||
| 75 | Research Facility | Magdeburg | Germany | ||
| 76 | Research Facility | Mannheim | Germany | ||
| 77 | Research Facility | Tubingen | Germany | ||
| 78 | Research Facility | Gdansk | Poland | ||
| 79 | Research Facility | Katowice | Poland | ||
| 80 | Research Facility | Lublin | Poland | ||
| 81 | Research Facility | Szczecin | Poland | ||
| 82 | Research Facility | Warszawa | Poland | ||
| 83 | Research Facility | Barcelona | Spain | ||
| 84 | Research Facility | Madrid | Spain | ||
| 85 | Research Facility | Malaga | Spain | ||
| 86 | Research Facility | Valencia | Spain |
Sponsors and Collaborators
- Forest Laboratories
Investigators
- Study Director: Jose M Brum, MD, Procter and Gamble
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00751738
Other Study ID Numbers:
- 2001060
First Posted:
Sep 12, 2008
Last Update Posted:
Feb 1, 2017
Last Verified:
Jan 1, 2017