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Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

Primary Purpose

Atrial Flutter, Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RSD1235
placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring Atrial Flutters, Atrial Fibrillations, RSD1235

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm

Secondary Outcome Measures

To assess the time taken from exposure to first treatment to first conversion to sinus rhythm

Full Information

First Posted
June 26, 2005
Last Updated
March 29, 2008
Sponsor
Astellas Pharma Inc
Collaborators
Advanz Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00115791
Brief Title
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

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Advanz Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter, Atrial Fibrillation
Keywords
Atrial Flutters, Atrial Fibrillations, RSD1235

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RSD1235
Other Intervention Name(s)
vernakalant, Kynapid
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
IV
Primary Outcome Measure Information:
Title
To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm
Time Frame
Infusion plus 1.5 hours
Secondary Outcome Measure Information:
Title
To assess the time taken from exposure to first treatment to first conversion to sinus rhythm
Time Frame
End of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Investigative Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Investigative Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Investigative Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Investigative Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Investigative Site
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Investigative Site
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Investigative Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Investigative Site
City
Holmdel
State/Province
New Jersey
ZIP/Postal Code
07733
Country
United States
Facility Name
Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Investigative Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Investigative Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Investigative Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
544449
Country
United States
Facility Name
Investigative Site
City
Buenos Aires
ZIP/Postal Code
B8185XAN
Country
Argentina
Facility Name
Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Facility Name
Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1064AAR
Country
Argentina
Facility Name
Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Investigative Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Investigative Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Investigative Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y K1Y
Country
Canada
Facility Name
Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Investigative Site
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Facility Name
Investigative Site
City
Santiago
State/Province
Cironaria
Country
Chile
Facility Name
Investigative Site
City
Aalborg
Country
Denmark
Facility Name
Investigative Site
City
Arhus C
Country
Denmark
Facility Name
Investigative Site
City
Esbjerg
Country
Denmark
Facility Name
Investigative Site
City
Fredericia
Country
Denmark
Facility Name
Investigative Site
City
Frederikssund
Country
Denmark
Facility Name
Investigative Site
City
Herlev
Country
Denmark
Facility Name
Investigative Site
City
Hjorring
Country
Denmark
Facility Name
Investigative Site
City
Holstebro
Country
Denmark
Facility Name
Investigative Site
City
Horsens
Country
Denmark
Facility Name
Investigative Site
City
Hvidovre
Country
Denmark
Facility Name
Investigative Site
City
Kobenhavn NV
Country
Denmark
Facility Name
Investigative Site
City
Kobenhavn S
Country
Denmark
Facility Name
Investigative Site
City
Koge
Country
Denmark
Facility Name
Investigative Site
City
Magdalena de las Salinas
Country
Mexico
Facility Name
Investigative Site
City
Malmo
Country
Sweden
Facility Name
Investigative Site
City
Molndal
Country
Sweden
Facility Name
Investigative Site
City
Orebro
Country
Sweden
Facility Name
Investigative Site
City
Stockholm
Country
Sweden
Facility Name
Investigative Site
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

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Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

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