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

December 17, 2008 updated by: Advanz Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Hospital
    • Quebec
      • Montréal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu
  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg Sygehus Syd
      • Aarhus, Denmark, 8000
        • Aarhus Sygehus Kardiologisk Afd. A
      • Frederiksberg, Denmark, 2000
        • Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital
      • Hellerup, Denmark
        • KAS Gentofte Kardiologisk Afdeling
      • Herlev, Denmark, 2730
        • KAS Herlev
      • Hjorring, Denmark, 9800
        • Sygehus Vendsyssel Hjorring
      • Kobenhavn, Denmark
        • Bispebjerg Hospital
      • Koge, Denmark, 4600
        • Roskilde Amts Sygehus Koge
      • Kolding, Denmark, 6000
        • Medicinsk Afdeling Kolding Sygehus
  • Netherlands
      • Delft, Netherlands
        • Reinier de Graaf Gasthuis
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Groningen, Netherlands
        • University Medical Center Groningen (UMCG)
      • Heerlen, Netherlands
        • Trial sectie Cardiologie
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
      • Nieuwegein, Netherlands
        • Stichting Sint Antonius Ziekenhuis
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • The Heart Center, P.C.
    • California
      • Walnut Creek, California, United States, 94598
        • Cardiovascular Consultants Medical Group, Inc.
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Heart & Vascular Institute
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d
Drug: Placebo comparator
Experimental: 2
Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d
Drug: Vernakalant (oral)
Other Names:
  • RSD1235-SR
Experimental: 3
Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d
Drug: Vernakalant (oral)
Other Names:
  • RSD1235-SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Subjects were assessed for safety within Day 58 of dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence of AF/AFL or withdrawal
Time Frame: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing
Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing
Improvement in AF symptoms
Time Frame: Time to improvement in AF symptoms within Day 28 of dosing
Time to improvement in AF symptoms within Day 28 of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanz Pharma

Investigators

  • Study Director: Greg Beatch, PhD, Advanz Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1235-SR-1005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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