Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery - Full Text View

Sponsor:	Astellas Pharma Inc
Collaborators:	Astellas Pharma US, Inc. Cardiome Pharma
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00125320

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation Atrial Flutter	Drug: RSD1235	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase III Study of the Conversion Efficacy and Safety of Repeated Intravenous Doses of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter Following Valvular and/or Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Coronary Artery Bypass Surgery Surgery

Drug Information available for: RSD 1235

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Effectiveness of RSD1235 [ Time Frame: 90 minutes post infusion ]

Secondary Outcome Measures:

Proportion of patients in sinus rhythm at 90 minutes [ Time Frame: Time from first exposure to conversion to sinus rhythm ]

Enrollment:	190
Study Start Date:	June 2004
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unstable Class IV heart failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125320

Locations

United States, Florida

Fort Lauderdale, Florida, United States, 33308
United States, Georgia

Atlanta, Georgia, United States
Argentina

Buenos Aires, Argentina

La Plata, Argentina
Canada, Alberta

Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario

Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec

Montreal, Quebec, Canada, H2L 4M1

Montreal, Quebec, Canada, H2W 1T8
Denmark, DK

Aalborg, DK, Denmark, 9000

Hellerup, DK, Denmark, 2900

Odense C, DK, Denmark, 5000
India

Bangalore, India, 562 158

Chennai, India, 600 037

Hyderabaad, India, 500 001

Kerala, India, 682 026

Mohali, India, 160 062

Mumbai, India, 400 051

New Delhi, India, 110 025
Poland

Katowice, Poland, 40-635

Krakow, Poland, 31-202

Lodz, Poland, 91-425

Warsaw, Poland

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma US, Inc.

Cardiome Pharma

Investigators

Study Director:

Medical Monitor

Astellas Pharma US, Inc.

More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	1235-0104
Study First Received:	July 28, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00125320 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Treatment

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases

Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on March 18, 2010