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

NCT ID: NCT00115791

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Flutter Atrial Fibrillation

Keywords

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Atrial Flutters Atrial Fibrillations RSD1235

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

RSD1235

Intervention Type DRUG

IV

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

IV

Interventions

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RSD1235

IV

Intervention Type DRUG

placebo

IV

Intervention Type DRUG

Other Intervention Names

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vernakalant Kynapid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanz Pharma

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma US, Inc.

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Investigative Site

Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Gainesville, Florida, United States

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Orlando, Florida, United States

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Port Charlotte, Florida, United States

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Indianapolis, Indiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Lansing, Michigan, United States

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Petoskey, Michigan, United States

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Saint Paul, Minnesota, United States

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Tupelo, Mississippi, United States

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Holmdel, New Jersey, United States

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Cincinnati, Ohio, United States

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Amarillo, Texas, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Marshfield, Wisconsin, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Halifax, Nova Scotia, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Terrebonne, Quebec, Canada

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Santiago, Cironaria, Chile

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Aalborg, , Denmark

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Arhus C, , Denmark

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Esbjerg, , Denmark

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Fredericia, , Denmark

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Frederikssund, , Denmark

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Herlev, , Denmark

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Hjørring, , Denmark

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Holstebro, , Denmark

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Horsens, , Denmark

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Hvidovre, , Denmark

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København NV, , Denmark

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København S, , Denmark

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Køge, , Denmark

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Magdalena de las Salinas, , Mexico

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Malmo, , Sweden

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Mölndal, , Sweden

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Örebro, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Countries

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United States Argentina Canada Chile Denmark Mexico Sweden

Other Identifiers

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Cardiome 1235-0504

Identifier Type: -

Identifier Source: secondary_id

04-7-010

Identifier Type: -

Identifier Source: org_study_id