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OpenTrials
Completed

NCT Number: NCT00281554

Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation

This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac 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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject must have symptomatic AF
  • Subject must have adequate anticoagulant therapy

Exclusion criteria

  • Subject may not have Class IV congestive heart failure.
  • Subject may not have uncorrected electrolyte imbalance.

Treatment and study plan

RSD1235

Drug

IV

Other names: vernakalant, Kynapid

Primary outcomes

  1. Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute

    Time frame: Infusion plus 1.5 hours

Secondary outcomes

  1. Evaluate safety

    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, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation

Acronym: ACT 4

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 25, 2006
Registry last updated
Apr 3, 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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