ACT 4: Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation
Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00281554
Collaborator
Advanz Pharma (Industry)
254
40
1
15
6.4
0.4
Study Details
Study Description
Brief Summary
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
254 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation
Study Start Date
:
Oct 1, 2005
Actual Primary Completion Date
:
Jan 1, 2007
Actual Study Completion Date
:
Jan 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: RSD1235
IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute [Infusion plus 1.5 hours]
Secondary Outcome Measures
- Evaluate safety [End of study]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject must have symptomatic AF
-
Subject must have adequate anticoagulant therapy
Exclusion Criteria:
-
Subject may not have Class IV congestive heart failure.
-
Subject may not have uncorrected electrolyte imbalance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huntsville | Alabama | United States | 35801 | |
| 2 | Atlanta | Georgia | United States | 30322 | |
| 3 | Chicago | Illinois | United States | 60637 | |
| 4 | Oak Lawn | Illinois | United States | 60453 | |
| 5 | Boston | Massachusetts | United States | 02135 | |
| 6 | Lansing | Michigan | United States | 48910 | |
| 7 | Austin | Texas | United States | 78756 | |
| 8 | San Antonio | Texas | United States | 78229 | |
| 9 | Richmond | Virginia | United States | 23249 | |
| 10 | Marshfield | Wisconsin | United States | 54449 | |
| 11 | Buenos Aires | Argentina | B8185SAN | ||
| 12 | Buenos Aires | Argentina | C1064AAR | ||
| 13 | Buenos Aires | Argentina | C1406GZL | ||
| 14 | Buenos Aires | Argentina | CP1280 | ||
| 15 | Buenos Aires | Argentina | CP1437 | ||
| 16 | Corrientes | Argentina | CP3400 | ||
| 17 | De Buenos Aires | Argentina | |||
| 18 | Rosario | Argentina | |||
| 19 | Tulunaw | Argentina | CP4000 | ||
| 20 | Calgary | Alberta | Canada | T2N 4N1 | |
| 21 | Ottawa | Ontario | Canada | K1Y 4E9 | |
| 22 | Montreal | Quebec | Canada | G2K 4N1 | |
| 23 | Montreal | Quebec | Canada | H2W 1T8 | |
| 24 | Terrebonne | Quebec | Canada | J6V 2H2 | |
| 25 | Aalborg | Denmark | DK-9000 | ||
| 26 | Esbjerg | Denmark | DK-9800 | ||
| 27 | Hjorring | Denmark | DK-9800 | ||
| 28 | Hvidovre | Denmark | DK-2650 | ||
| 29 | Kobenhavn NV | Denmark | DK-2400 | ||
| 30 | Koge | Denmark | 4600 | ||
| 31 | Berea Durban | South Africa | 4001 | ||
| 32 | Bloemfontein | South Africa | 9301 | ||
| 33 | Centurion | South Africa | 0157 | ||
| 34 | Parow | South Africa | 7500 | ||
| 35 | Somerset West | South Africa | 7130 | ||
| 36 | Westdene Bloemfontein | South Africa | 9301 | ||
| 37 | Malmo | Sweden | SE-205-02 | ||
| 38 | Molndal | Sweden | SE-431-80 | ||
| 39 | Orebro | Sweden | SE-701-85 | ||
| 40 | Stockholm | Sweden | SE-182-88 |
Sponsors and Collaborators
- Astellas Pharma Inc
- Advanz Pharma
Investigators
- Study Director: Use Central Contact, Astellas Pharma US, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00281554
Other Study ID Numbers:
- 05-7-012
First Posted:
Jan 25, 2006
Last Update Posted:
Apr 3, 2008
Last Verified:
Apr 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: