Arrhythmias Clinical Trial
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
| Verified date | January 2017 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 330 |
| Est. completion date | October 2005 |
| Est. primary completion date | October 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Facility | Brugge | |
| Belgium | Research Facility | Mont Godinne | |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Facility | Hamilton | Ontario |
| Canada | Research Facility | Montreal | Quebec |
| Canada | Research Facility | Ottawa | Ontario |
| Canada | Research Facility | Quebec | |
| Canada | Research Facility | St. Johns | Newfoundland and Labrador |
| Canada | Research Facility | Toronto | Ontario |
| Canada | Research Facility | Victoria | British Columbia |
| France | Research Facility | Lille Cedex | |
| France | Research Facility | Nantes Cedex | |
| France | Research Facility | Paris Cedex | |
| France | Research Facility | Pessac Cedex | |
| France | Research Facility | Tours Cedex | |
| Germany | Research Facility | Bad Bevensen | |
| Germany | Research Facility | Berlin | |
| Germany | Research Facility | Brandenburg an der Havel | |
| Germany | Research Facility | Coburg | |
| Germany | Research Facility | Frankfurt | |
| Germany | Research Facility | Freiburg | |
| Germany | Research Facility | Hamburg | |
| Germany | Research Facility | Heidelberg | |
| Germany | Research Facility | Ludwigshafen | |
| Germany | Research Facility | Magdeburg | |
| Germany | Research Facility | Mannheim | |
| Germany | Research Facility | Tubingen | |
| Poland | Research Facility | Gdansk | |
| Poland | Research Facility | Katowice | |
| Poland | Research Facility | Lublin | |
| Poland | Research Facility | Szczecin | |
| Poland | Research Facility | Warszawa | |
| Spain | Research Facility | Barcelona | |
| Spain | Research Facility | Madrid | |
| Spain | Research Facility | Malaga | |
| Spain | Research Facility | Valencia | |
| United States | Research Facility | Baltimore | Maryland |
| United States | Research Facility | Baltimore | Maryland |
| United States | Research Facility | Boston | Massachusetts |
| United States | Research Facility | Bridgeport | Connecticut |
| United States | Research Facility | Brooklyn | New York |
| United States | Research Facility | Burlington | Massachusetts |
| United States | Research Facility | Charleston | South Carolina |
| United States | Research Facility | Charlottesville | Virginia |
| United States | Research Facility | Cincinnati | Ohio |
| United States | Research Facility | Colorado Springs | Colorado |
| United States | Research Site | Columbia | South Carolina |
| United States | Research Facility | Dallas | Texas |
| United States | Research Facility | Dallas | Texas |
| United States | Research Site | Durham | North Carolina |
| United States | Research Facility | Erie | Pennsylvania |
| United States | Research Facility | Fairfax | Virginia |
| United States | Research Facility | Ft. Lauderdale | Florida |
| United States | Research Facility | Ft. Myers | Florida |
| United States | Research Facility | Germantown | Tennessee |
| United States | Research Facility | Green Bay | Wisconsin |
| United States | Research Facility | Hershey | Pennsylvania |
| United States | Research Facility | Houston | Texas |
| United States | Research Facility | Jacksonville | Florida |
| United States | Research Facility | Johnson City | New York |
| United States | Research Facility | Kansas City | Kansas |
| United States | Research Facility | LaJolla | California |
| United States | Research Facility | Lancaster | Pennsylvania |
| United States | Research Facility | Little Rock | Arkansas |
| United States | Research Facility | Loma Linda | California |
| United States | Research Facility | Maywood | Illinois |
| United States | Research Facility | Milwaukee | Wisconsin |
| United States | Research Facility | Mobile | Alabama |
| United States | Research Facility | Nashville | Tennessee |
| United States | Research Facility | New York | New York |
| United States | Research Facility | New York | New York |
| United States | Research Facility | Philadelphia | Pennsylvania |
| United States | Research Facility | Portland | Maine |
| United States | Research Facility | Rochester | New York |
| United States | Research Facility | Rochester | New York |
| United States | Research Facility | Sacramento | California |
| United States | Research Facility | Salt Lake City | Utah |
| United States | Research Facility | Spokane | Washington |
| United States | Research Facility | Toledo | Ohio |
| United States | Research Facility | Tulsa | Oklahoma |
| United States | Research Facility | Warren | New Jersey |
| United States | Research Facility | Washington | District of Columbia |
| United States | Research Facility | West Orange | New York |
| United States | Research Facility | Williamsville | New York |
| United States | Research Facility | Winston-Salem | North Carolina |
| United States | Research Facility | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States, Belgium, Canada, France, Germany, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | safety of azimilide in this patient population | 1 year |
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