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OpenTrials
Completed

NCT Number: NCT00115791

Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Atrial Fibrillation 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

Investigative Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days

Exclusion criteria

  • Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization

Treatment and study plan

RSD1235

Drug

IV

Other names: vernakalant, Kynapid

Placebo

Drug

IV

Primary outcomes

  1. To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm

    Time frame: Infusion plus 1.5 hours

Secondary outcomes

  1. To assess the time taken from exposure to first treatment to first conversion to sinus rhythm

    Time frame: End of study

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Advanz Pharma

Registry information

Official study title

A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 27, 2005
Registry last updated
Apr 1, 2008

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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