Clinical trial NCT00281554: Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation
Official title: A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Investigational Therapies
Atrial Fibrillation
Treatment Efficacy
Treatment Effectiveness
Safety
RSD1235
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Advanz Pharma
First posted: 2006-01-25
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute
timeFrame: Infusion plus 1.5 hours
Secondary outcomes:
measure: Evaluate safety
timeFrame: End of study
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Oak Lawn
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Marshfield
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Corrientes
country: Argentina
city: De Buenos Aires
country: Argentina
city: Rosario
country: Argentina
city: Tulunaw
country: Argentina
city: Calgary
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Terrebonne
country: Canada
state: Quebec
city: Aalborg
country: Denmark
city: Esbjerg
country: Denmark
city: Hjorring
country: Denmark
city: Hvidovre
country: Denmark
city: Kobenhavn NV
country: Denmark
city: Koge
country: Denmark
city: Berea Durban
country: South Africa
city: Bloemfontein
country: South Africa
city: Centurion
country: South Africa
city: Parow
country: South Africa
city: Somerset West
country: South Africa
city: Westdene Bloemfontein
country: South Africa
city: Malmo
country: Sweden
city: Molndal
country: Sweden
city: Orebro
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Stiell 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.