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Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation (ACT 4)

Primary Purpose

Atrial Fibrillation

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

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Investigational Therapies, Atrial Fibrillation, Treatment Efficacy, Treatment Effectiveness, Safety, RSD1235

Eligibility Criteria

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute

Secondary Outcome Measures

Evaluate safety

Full Information

First Posted
January 24, 2006
Last Updated
April 1, 2008
Sponsor
Astellas Pharma Inc
Collaborators
Advanz Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00281554
Brief Title
Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation
Acronym
ACT 4
Official Title
A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Advanz Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Investigational Therapies, Atrial Fibrillation, Treatment Efficacy, Treatment Effectiveness, Safety, RSD1235

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RSD1235
Other Intervention Name(s)
vernakalant, Kynapid
Intervention Description
IV
Primary Outcome Measure Information:
Title
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute
Time Frame
Infusion plus 1.5 hours
Secondary Outcome Measure Information:
Title
Evaluate safety
Time Frame
End of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
City
Buenos Aires
ZIP/Postal Code
B8185SAN
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1064AAR
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1406GZL
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
CP1280
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
CP1437
Country
Argentina
City
Corrientes
ZIP/Postal Code
CP3400
Country
Argentina
City
De Buenos Aires
Country
Argentina
City
Rosario
Country
Argentina
City
Tulunaw
ZIP/Postal Code
CP4000
Country
Argentina
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
G2K 4N1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
City
Esbjerg
ZIP/Postal Code
DK-9800
Country
Denmark
City
Hjorring
ZIP/Postal Code
DK-9800
Country
Denmark
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
City
Kobenhavn NV
ZIP/Postal Code
DK-2400
Country
Denmark
City
Koge
ZIP/Postal Code
4600
Country
Denmark
City
Berea Durban
ZIP/Postal Code
4001
Country
South Africa
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
City
Centurion
ZIP/Postal Code
0157
Country
South Africa
City
Parow
ZIP/Postal Code
7500
Country
South Africa
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
City
Westdene Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
City
Malmo
ZIP/Postal Code
SE-205-02
Country
Sweden
City
Molndal
ZIP/Postal Code
SE-431-80
Country
Sweden
City
Orebro
ZIP/Postal Code
SE-701-85
Country
Sweden
City
Stockholm
ZIP/Postal Code
SE-182-88
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21175515
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. Erratum In: Acad Emerg Med. 2011 Feb;18(2):224.
Results Reference
derived
PubMed Identifier
20569725
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.
Results Reference
derived

Learn more about this trial

Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation

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