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

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Vernakalant (oral); Drug: Placebo comparator

• Registration Number: NCT00267930
• Lead Sponsor: Advanz Pharma

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-20
• Study First Submitted QC: 2005-12-20
• Study First Posted: 2005-12-22
• Study Completion: 2006-08
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-17
• Last Update Posted: 2008-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Vernakalant (oral)	Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d
3	Vernakalant (oral)	Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d
1	Placebo comparator	Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d

Primary Outcome Measures

Name	Time	Method
All subjects who were exposed to the investigational medication were evaluated for safety.	Subjects were assessed for safety within Day 58 of dosing

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (22)

Sygehus Vendsyssel Hjorring; 🇩🇰 Hjorring, Denmark

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Foothills Hospital; 🇨🇦 Calgary, Alberta, Canada

Marshfield Clinic; 🇺🇸 Marshfield, Wisconsin, United States

Aalborg Sygehus Syd; 🇩🇰 Aalborg, Denmark

Cardiovascular Consultants Medical Group, Inc.; 🇺🇸 Walnut Creek, California, United States

The Heart Center, P.C.; 🇺🇸 Huntsville, Alabama, United States

Penn State Heart & Vascular Institute; 🇺🇸 Hershey, Pennsylvania, United States

Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu; 🇨🇦 Montréal, Quebec, Canada

Aarhus Sygehus Kardiologisk Afd. A; 🇩🇰 Aarhus, Denmark

Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark

KAS Gentofte Kardiologisk Afdeling; 🇩🇰 Hellerup, Denmark

Medicinsk Afdeling Kolding Sygehus; 🇩🇰 Kolding, Denmark

KAS Herlev; 🇩🇰 Herlev, Denmark

Bispebjerg Hospital; 🇩🇰 Kobenhavn, Denmark

Roskilde Amts Sygehus Koge; 🇩🇰 Koge, Denmark

University Medical Center Groningen (UMCG); 🇳🇱 Groningen, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Trial sectie Cardiologie; 🇳🇱 Heerlen, Netherlands

Stichting Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands