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

Tracking Information

First Received Date ^ICMJE

July 28, 2005

Last Updated Date

December 19, 2007

Start Date ^ICMJE

June 2004

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00125320 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Atrial Fibrillation
Atrial Flutter

Intervention ^ICMJE

Drug: RSD1235

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

190

Completion Date

February 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Unstable Class IV heart failure

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Canada, Denmark, India, Poland

Administrative Information

NCT ID ^ICMJE

NCT00125320

Responsible Party

Study ID Numbers ^ICMJE

1235-0104

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Astellas Pharma US, Inc.
Cardiome Pharma

Investigators ^ICMJE

Study Director:

Medical Monitor

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP