Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery

NCT ID: NCT00125320

Last Updated: 2007-12-24

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

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-02-28

Brief Summary

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The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.

Detailed Description

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This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.

Conditions

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Atrial Fibrillation Atrial Flutter

Keywords

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Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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RSD1235

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery

Exclusion Criteria

* Unstable Class IV heart failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Advanz Pharma

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Fort Lauderdale, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Buenos Aires, , Argentina

Site Status

La Plata, , Argentina

Site Status

Calgary, Alberta, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Aalborg, DK, Denmark

Site Status

Hellerup, DK, Denmark

Site Status

Odense C, DK, Denmark

Site Status

Bangalore, , India

Site Status

Chennai, , India

Site Status

Hyderabaad, , India

Site Status

Kerala, , India

Site Status

Mohali, , India

Site Status

Mumbai, , India

Site Status

New Delhi, , India

Site Status

Katowice, , Poland

Site Status

Krakow, , Poland

Site Status

Lodz, , Poland

Site Status

Warsaw, , Poland

Site Status

Countries

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United States Argentina Canada Denmark India Poland

References

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Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204.

Reference Type DERIVED
PMID: 19948506 (View on PubMed)

Other Identifiers

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1235-0104

Identifier Type: -

Identifier Source: org_study_id