Clinical trial NCT00267930: Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: AFib
AF
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: All subjects who were exposed to the investigational medication were evaluated for safety.
timeFrame: Subjects were assessed for safety within Day 58 of dosing
Secondary outcomes:
measure: Recurrence of AF/AFL or withdrawal
timeFrame: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing
measure: Improvement in AF symptoms
timeFrame: Time to improvement in AF symptoms within Day 28 of dosing
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Heart Center, P.C.
state: Alabama
city: Walnut Creek
country: United States
facility: Cardiovascular Consultants Medical Group, Inc.
state: California
city: Hershey
country: United States
facility: Penn State Heart & Vascular Institute
state: Pennsylvania
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu
state: Quebec
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Syd
city: Aarhus
country: Denmark
facility: Aarhus Sygehus Kardiologisk Afd. A
city: Frederiksberg
country: Denmark
facility: Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital
city: Hellerup
country: Denmark
facility: KAS Gentofte Kardiologisk Afdeling
city: Herlev
country: Denmark
facility: KAS Herlev
city: Hjorring
country: Denmark
facility: Sygehus Vendsyssel Hjorring
city: Kobenhavn
country: Denmark
facility: Bispebjerg Hospital
city: Koge
country: Denmark
facility: Roskilde Amts Sygehus Koge
city: Kolding
country: Denmark
facility: Medicinsk Afdeling Kolding Sygehus
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
city: Heerlen
country: Netherlands
facility: Trial sectie Cardiologie
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Nieuwegein
country: Netherlands
facility: Stichting Sint Antonius Ziekenhuis
Study officials:
affiliation: Advanz Pharma
name: Greg Beatch, PhD
role: STUDY_DIRECTOR
References: