Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
2 other identifiers
interventional
276
7 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2004
Shorter than P25 for phase_3
54 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
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 26, 2005
CompletedFirst Posted
Study publicly available on registry
June 27, 2005
CompletedApril 1, 2008
March 1, 2008
1 year
June 26, 2005
March 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm
Infusion plus 1.5 hours
Secondary Outcomes (1)
To assess the time taken from exposure to first treatment to first conversion to sinus rhythm
End of study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days
You may not qualify if:
- Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Advanz Pharmacollaborator
Study Sites (54)
Investigative Site
Birmingham, Alabama, 35213, United States
Investigative Site
Huntsville, Alabama, 35801, United States
Investigative Site
Gainesville, Florida, 32610, United States
Investigative Site
Orlando, Florida, 32803, United States
Investigative Site
Port Charlotte, Florida, 33952, United States
Investigative Site
Indianapolis, Indiana, 46202, United States
Investigative Site
Shreveport, Louisiana, 71103, United States
Investigative Site
Baltimore, Maryland, 21201, United States
Investigative Site
Lansing, Michigan, 48910, United States
Investigative Site
Petoskey, Michigan, 49770, United States
Investigative Site
Saint Paul, Minnesota, 55102, United States
Investigative Site
Tupelo, Mississippi, 38801, United States
Investigative Site
Holmdel, New Jersey, 07733, United States
Investigative Site
Cincinnati, Ohio, 45267, United States
Investigative Site
Amarillo, Texas, 79106, United States
Investigative Site
Houston, Texas, 77030, United States
Investigative Site
Richmond, Virginia, 23249, United States
Investigative Site
Tacoma, Washington, 98405, United States
Investigative Site
Marshfield, Wisconsin, 544449, United States
Investigative Site
Buenos Aires, B8185XAN, Argentina
Investigative Site
Buenos Aires, C1039AAO, Argentina
Investigative Site
Buenos Aires, C1064AAR, Argentina
Investigative Site
Buenos Aires, C1221ADC, Argentina
Investigative Site
Mendoza, 5500, Argentina
Investigative Site
Calgary, Alberta, T2N 2T9, Canada
Investigative Site
Edmonton, Alberta, T6G 2B7, Canada
Investigative Site
Halifax, Nova Scotia, B3H 1V7, Canada
Investigative Site
Ottawa, Ontario, K1Y 4E9, Canada
Investigative Site
Ottawa, Ontario, K1Y K1Y, Canada
Investigative Site
Toronto, Ontario, M5B 1W8, Canada
Investigative Site
Montreal, Quebec, H1T 1C8, Canada
Investigative Site
Montreal, Quebec, H2L 4M1, Canada
Investigative Site
Montreal, Quebec, H2W 1T8, Canada
Investigative Site
Terrebonne, Quebec, J6V 2H2, Canada
Investigative Site
Santiago, Cironaria, Chile
Investigative Site
Aalborg, Denmark
Investigative Site
Arhus C, Denmark
Investigative Site
Esbjerg, Denmark
Investigative Site
Fredericia, Denmark
Investigative Site
Frederikssund, Denmark
Investigative Site
Herlev, Denmark
Investigative Site
Hjørring, Denmark
Investigative Site
Holstebro, Denmark
Investigative Site
Horsens, Denmark
Investigative Site
Hvidovre, Denmark
Investigative Site
København NV, Denmark
Investigative Site
København S, Denmark
Investigative Site
Køge, Denmark
Investigative Site
Magdalena de las Salinas, Mexico
Investigative Site
Malmo, Sweden
Investigative Site
Mölndal, Sweden
Investigative Site
Örebro, Sweden
Investigative Site
Stockholm, Sweden
Investigative Site
Uppsala, Sweden
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 26, 2005
First Posted
June 27, 2005
Study Start
June 1, 2004
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
April 1, 2008
Record last verified: 2008-03