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OpenTrials
Completed

NCT Number: NCT00267930

Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence

This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration

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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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Foothills Hospital, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(partial list):

  • Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration
  • Subjects must have adequate anticoagulant therapy

Exclusion criteria

(partial list):

  • Subjects may not have Class III or Class IV congestive heart failure
  • Subjects may not have uncorrected electrolyte imbalance

Treatment and study plan

Vernakalant (oral)

Drug

Other names: RSD1235-SR

placebo comparator

Drug

Primary outcomes

  1. All subjects who were exposed to the investigational medication were evaluated for safety.

    Time frame: Subjects were assessed for safety within Day 58 of dosing

Secondary outcomes

  1. Recurrence of AF/AFL or withdrawal

    Time frame: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing

  2. Improvement in AF symptoms

    Time frame: Time to improvement in AF symptoms within Day 28 of dosing

Sponsors and collaborators

Lead sponsor

Advanz Pharma

Industry

Registry information

Official study title

A Pilot Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centred Safety, Tolerability and Preliminary Efficacy Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion Form AF

Important dates

Study start
2005
Study completion
2006
First posted
Dec 22, 2005
Registry last updated
Dec 18, 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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