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

March 29, 2008 updated by: Astellas Pharma Inc

A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

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, B8185XAN
        • Investigative Site
      • Buenos Aires, Argentina, C1039AAO
        • Investigative Site
      • Buenos Aires, Argentina, C1064AAR
        • Investigative Site
      • Buenos Aires, Argentina, C1221ADC
        • Investigative Site
      • Mendoza, Argentina, 5500
        • Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Investigative Site
      • Edmonton, Alberta, Canada, T6G 2B7
        • Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Investigative Site
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Investigative Site
      • Ottawa, Ontario, Canada, K1Y K1Y
        • Investigative Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Investigative Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Investigative Site
      • Montreal, Quebec, Canada, H2W 1T8
        • Investigative Site
      • Terrebonne, Quebec, Canada, J6V 2H2
        • Investigative Site
  • Chile
    • Cironaria
      • Santiago, Cironaria, Chile
        • Investigative Site
  • Denmark
      • 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
      • Hjorring, Denmark
        • Investigative Site
      • Holstebro, Denmark
        • Investigative Site
      • Horsens, Denmark
        • Investigative Site
      • Hvidovre, Denmark
        • Investigative Site
      • Kobenhavn NV, Denmark
        • Investigative Site
      • Kobenhavn S, Denmark
        • Investigative Site
      • Koge, Denmark
        • Investigative Site
  • Mexico
      • Magdalena de las Salinas, Mexico
        • Investigative Site
  • Sweden
      • Malmo, Sweden
        • Investigative Site
      • Molndal, Sweden
        • Investigative Site
      • Orebro, Sweden
        • Investigative Site
      • Stockholm, Sweden
        • Investigative Site
      • Uppsala, Sweden
        • Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Investigative Site
      • Huntsville, Alabama, United States, 35801
        • Investigative Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Investigative Site
      • Orlando, Florida, United States, 32803
        • Investigative Site
      • Port Charlotte, Florida, United States, 33952
        • Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Investigative Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Investigative Site
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Investigative Site
      • Petoskey, Michigan, United States, 49770
        • Investigative Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • Investigative Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Investigative Site
    • New Jersey
      • Holmdel, New Jersey, United States, 07733
        • Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Investigative Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Investigative Site
      • Houston, Texas, United States, 77030
        • Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Investigative Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Investigative Site
    • Wisconsin
      • Marshfield, Wisconsin, United States, 544449
        • Investigative Site

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:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: RSD1235
IV
Other Names:
  • vernakalant
  • Kynapid
Placebo Comparator: 2
Drug: placebo
IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Infusion plus 1.5 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the time taken from exposure to first treatment to first conversion to sinus rhythm
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

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

June 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

June 26, 2005

First Submitted That Met QC Criteria

June 26, 2005

First Posted (Estimate)

June 27, 2005

Study Record Updates

Last Update Posted (Estimate)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 29, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-7-010
  • Cardiome 1235-0504

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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