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Completed

NCT Number: NCT00125320

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unstable Class IV heart failure

Treatment and study plan

RSD1235

Drug

Primary outcomes

  1. Effectiveness of RSD1235

    Time frame: 90 minutes post infusion

Secondary outcomes

  1. Proportion of patients in sinus rhythm at 90 minutes

    Time frame: Time from first exposure to conversion to sinus rhythm

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Advanz Pharma
  • Astellas Pharma US, Inc.

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 1, 2005
Registry last updated
Dec 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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