Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation

NCT ID: NCT00281554

Last Updated: 2008-04-03

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

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-01-31

Brief Summary

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

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Investigational Therapies Atrial Fibrillation Treatment Efficacy Treatment Effectiveness Safety RSD1235

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RSD1235

Intervention Type DRUG

IV

Interventions

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RSD1235

IV

Intervention Type DRUG

Other Intervention Names

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vernakalant Kynapid

Eligibility Criteria

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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.
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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Huntsville, Alabama, United States

Site Status

Atlanta, Georgia, United States

Site Status

Chicago, Illinois, United States

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Oak Lawn, Illinois, United States

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Boston, Massachusetts, United States

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Lansing, Michigan, United States

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Austin, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, 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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Buenos Aires, , Argentina

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Corrientes, , Argentina

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De Buenos Aires, , Argentina

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Rosario, , Argentina

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Tulunaw, , Argentina

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Calgary, Alberta, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

Site Status

Montreal, Quebec, Canada

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Terrebonne, Quebec, Canada

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Aalborg, , Denmark

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Esbjerg, , Denmark

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Hjørring, , Denmark

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Hvidovre, , Denmark

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København NV, , Denmark

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Køge, , Denmark

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Berea Durban, , South Africa

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Bloemfontein, , South Africa

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Centurion, , South Africa

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Parow, , South Africa

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Somerset West, , South Africa

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Westdene Bloemfontein, , South Africa

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Malmo, , Sweden

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Mölndal, , Sweden

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Örebro, , Sweden

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Stockholm, , Sweden

Site Status

Countries

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United States Argentina Canada Denmark South Africa Sweden

References

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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.

Reference Type DERIVED
PMID: 21175515 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20569725 (View on PubMed)

Other Identifiers

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05-7-012

Identifier Type: -

Identifier Source: org_study_id