Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation
ACT 4
A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation
1 other identifier
interventional
254
6 countries
40
Brief Summary
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Oct 2005
Shorter than P25 for phase_3 atrial-fibrillation
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 24, 2006
CompletedFirst Posted
Study publicly available on registry
January 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedApril 3, 2008
April 1, 2008
1.3 years
January 24, 2006
April 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute
Infusion plus 1.5 hours
Secondary Outcomes (1)
Evaluate safety
End of study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subject must have symptomatic AF
- Subject must have adequate anticoagulant therapy
You may not qualify if:
- Subject may not have Class IV congestive heart failure.
- Subject may not have uncorrected electrolyte imbalance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Advanz Pharmacollaborator
Study Sites (40)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Oak Lawn, Illinois, 60453, United States
Unknown Facility
Boston, Massachusetts, 02135, United States
Unknown Facility
Lansing, Michigan, 48910, United States
Unknown Facility
Austin, Texas, 78756, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Marshfield, Wisconsin, 54449, United States
Unknown Facility
Buenos Aires, B8185SAN, Argentina
Unknown Facility
Buenos Aires, C1064AAR, Argentina
Unknown Facility
Buenos Aires, C1406GZL, Argentina
Unknown Facility
Buenos Aires, CP1280, Argentina
Unknown Facility
Buenos Aires, CP1437, Argentina
Unknown Facility
Corrientes, CP3400, Argentina
Unknown Facility
De Buenos Aires, Argentina
Unknown Facility
Rosario, Argentina
Unknown Facility
Tulunaw, CP4000, Argentina
Unknown Facility
Calgary, Alberta, T2N 4N1, Canada
Unknown Facility
Ottawa, Ontario, K1Y 4E9, Canada
Unknown Facility
Montreal, Quebec, G2K 4N1, Canada
Unknown Facility
Montreal, Quebec, H2W 1T8, Canada
Unknown Facility
Terrebonne, Quebec, J6V 2H2, Canada
Unknown Facility
Aalborg, DK-9000, Denmark
Unknown Facility
Esbjerg, DK-9800, Denmark
Unknown Facility
Hjørring, DK-9800, Denmark
Unknown Facility
Hvidovre, DK-2650, Denmark
Unknown Facility
København NV, DK-2400, Denmark
Unknown Facility
Køge, 4600, Denmark
Unknown Facility
Berea Durban, 4001, South Africa
Unknown Facility
Bloemfontein, 9301, South Africa
Unknown Facility
Centurion, 0157, South Africa
Unknown Facility
Parow, 7500, South Africa
Unknown Facility
Somerset West, 7130, South Africa
Unknown Facility
Westdene Bloemfontein, 9301, South Africa
Unknown Facility
Malmo, SE-205-02, Sweden
Unknown Facility
Mölndal, SE-431-80, Sweden
Unknown Facility
Örebro, SE-701-85, Sweden
Unknown Facility
Stockholm, SE-182-88, Sweden
Related Publications (2)
Stiell IG, Dickinson G, Butterfield NN, Clement CM, Perry JJ, Vaillancourt C, Calder LA. Vernakalant hydrochloride: A novel atrial-selective agent for the cardioversion of recent-onset atrial fibrillation in the emergency department. Acad Emerg Med. 2010 Nov;17(11):1175-82. doi: 10.1111/j.1553-2712.2010.00915.x.
PMID: 21175515DERIVEDStiell IG, Roos JS, Kavanagh KM, Dickinson G. A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm. Am Heart J. 2010 Jun;159(6):1095-101. doi: 10.1016/j.ahj.2010.02.035.
PMID: 20569725DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 24, 2006
First Posted
January 25, 2006
Study Start
October 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
April 3, 2008
Record last verified: 2008-04