Clinical trial NCT00115791: Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
Official title: A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Flutter
Atrial Fibrillation
Keywords: Atrial Flutters
Atrial Fibrillations
RSD1235
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Advanz Pharma
First posted: 2005-06-27
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.


Eligibility criteria: Inclusion Criteria:

* Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days

Exclusion Criteria:

* Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization

Primary outcomes:
measure: To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm
timeFrame: Infusion plus 1.5 hours
Secondary outcomes:
measure: To assess the time taken from exposure to first treatment to first conversion to sinus rhythm
timeFrame: End of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site
state: Alabama
city: Huntsville
country: United States
facility: Investigative Site
state: Alabama
city: Gainesville
country: United States
facility: Investigative Site
state: Florida
city: Orlando
country: United States
facility: Investigative Site
state: Florida
city: Port Charlotte
country: United States
facility: Investigative Site
state: Florida
city: Indianapolis
country: United States
facility: Investigative Site
state: Indiana
city: Shreveport
country: United States
facility: Investigative Site
state: Louisiana
city: Baltimore
country: United States
facility: Investigative Site
state: Maryland
city: Lansing
country: United States
facility: Investigative Site
state: Michigan
city: Petoskey
country: United States
facility: Investigative Site
state: Michigan
city: St. Paul
country: United States
facility: Investigative Site
state: Minnesota
city: Tupelo
country: United States
facility: Investigative Site
state: Mississippi
city: Holmdel
country: United States
facility: Investigative Site
state: New Jersey
city: Cincinnati
country: United States
facility: Investigative Site
state: Ohio
city: Amarillo
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Richmond
country: United States
facility: Investigative Site
state: Virginia
city: Tacoma
country: United States
facility: Investigative Site
state: Washington
city: Marshfield
country: United States
facility: Investigative Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Mendoza
country: Argentina
facility: Investigative Site
city: Calgary
country: Canada
facility: Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Investigative Site
state: Alberta
city: Halifax
country: Canada
facility: Investigative Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Investigative Site
state: Quebec
city: Terrebonne
country: Canada
facility: Investigative Site
state: Quebec
city: Santiago
country: Chile
facility: Investigative Site
state: Cironaria
city: Aalborg
country: Denmark
facility: Investigative Site
city: Arhus C
country: Denmark
facility: Investigative Site
city: Esbjerg
country: Denmark
facility: Investigative Site
city: Fredericia
country: Denmark
facility: Investigative Site
city: Frederikssund
country: Denmark
facility: Investigative Site
city: Herlev
country: Denmark
facility: Investigative Site
city: Hjorring
country: Denmark
facility: Investigative Site
city: Holstebro
country: Denmark
facility: Investigative Site
city: Horsens
country: Denmark
facility: Investigative Site
city: Hvidovre
country: Denmark
facility: Investigative Site
city: Kobenhavn NV
country: Denmark
facility: Investigative Site
city: Kobenhavn S
country: Denmark
facility: Investigative Site
city: Koge
country: Denmark
facility: Investigative Site
city: Magdalena de las Salinas
country: Mexico
facility: Investigative Site
city: Malmo
country: Sweden
facility: Investigative Site
city: Molndal
country: Sweden
facility: Investigative Site
city: Orebro
country: Sweden
facility: Investigative Site
city: Stockholm
country: Sweden
facility: Investigative Site
city: Uppsala
country: Sweden
facility: Investigative Site
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References: