NCT00267930

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for phase_2 atrial-fibrillation

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach
4 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

December 18, 2008

Status Verified

December 1, 2008

First QC Date

December 20, 2005

Last Update Submit

December 17, 2008

Conditions

Atrial Fibrillation

Keywords

AFibAF

Outcome Measures

Primary Outcomes (1)

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

    Subjects were assessed for safety within Day 58 of dosing

Secondary Outcomes (2)

  • Recurrence of AF/AFL or withdrawal

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

  • Improvement in AF symptoms

    Time to improvement in AF symptoms within Day 28 of dosing

Study Arms (3)

1

PLACEBO COMPARATOR

Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d

Drug: Placebo comparator

2

EXPERIMENTAL

Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d

Drug: Vernakalant (oral)

3

EXPERIMENTAL

Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d

Drug: Vernakalant (oral)

Interventions

Vernakalant (oral)DRUG
Also known as: RSD1235-SR
23
Placebo comparatorDRUG
1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

The Heart Center, P.C.

Huntsville, Alabama, 35801, United States

Location

Cardiovascular Consultants Medical Group, Inc.

Walnut Creek, California, 94598, United States

Location

Penn State Heart & Vascular Institute

Hershey, Pennsylvania, 17033, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Aalborg Sygehus Syd

Aalborg, 9100, Denmark

Location

Aarhus Sygehus Kardiologisk Afd. A

Aarhus, 8000, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

KAS Gentofte Kardiologisk Afdeling

Hellerup, Denmark

Location

KAS Herlev

Herlev, 2730, Denmark

Location

Sygehus Vendsyssel Hjorring

Hjørring, 9800, Denmark

Location

Medicinsk Afdeling Kolding Sygehus

Kolding, 6000, Denmark

Location

Roskilde Amts Sygehus Koge

Køge, 4600, Denmark

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

University Medical Center Groningen (UMCG)

Groningen, Netherlands

Location

Trial sectie Cardiologie

Heerlen, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

Stichting Sint Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

vernakalant

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Greg Beatch, PhD

    Advanz Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

December 1, 2005

Study Completion

August 1, 2006

Last Updated

December 18, 2008

Record last verified: 2008-12

Locations

DK(9)US(4)CA(2)NL(7)