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

April 1, 2008 updated by: Astellas Pharma Inc

A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B8185SAN
      • Buenos Aires, Argentina, C1064AAR
      • Buenos Aires, Argentina, C1406GZL
      • Buenos Aires, Argentina, CP1280
      • Buenos Aires, Argentina, CP1437
      • Corrientes, Argentina, CP3400
      • De Buenos Aires, Argentina
      • Rosario, Argentina
      • Tulunaw, Argentina, CP4000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
      • Montreal, Quebec, Canada, G2K 4N1
      • Terrebonne, Quebec, Canada, J6V 2H2
  • Denmark
      • Aalborg, Denmark, DK-9000
      • Esbjerg, Denmark, DK-9800
      • Hjorring, Denmark, DK-9800
      • Hvidovre, Denmark, DK-2650
      • Kobenhavn NV, Denmark, DK-2400
      • Koge, Denmark, 4600
  • South Africa
      • Berea Durban, South Africa, 4001
      • Bloemfontein, South Africa, 9301
      • Centurion, South Africa, 0157
      • Parow, South Africa, 7500
      • Somerset West, South Africa, 7130
      • Westdene Bloemfontein, South Africa, 9301
  • Sweden
      • Malmo, Sweden, SE-205-02
      • Molndal, Sweden, SE-431-80
      • Orebro, Sweden, SE-701-85
      • Stockholm, Sweden, SE-182-88
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Oak Lawn, Illinois, United States, 60453
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
    • Michigan
      • Lansing, Michigan, United States, 48910
    • Texas
      • Austin, Texas, United States, 78756
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Richmond, Virginia, United States, 23249
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: RSD1235
IV
Other Names:
  • vernakalant
  • Kynapid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute
Time Frame: Infusion plus 1.5 hours
Infusion plus 1.5 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate safety
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Advanz Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria

January 24, 2006

First Posted (Estimate)

January 25, 2006

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

April 1, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-7-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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