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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vernakalant (oral)
Placebo comparator
Sponsored by
Advanz Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring AFib, AF

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Heart Center, P.C.
  • Cardiovascular Consultants Medical Group, Inc.
  • Penn State Heart & Vascular Institute
  • Marshfield Clinic
  • Foothills Hospital
  • Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu
  • Aalborg Sygehus Syd
  • Aarhus Sygehus Kardiologisk Afd. A
  • Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital
  • KAS Gentofte Kardiologisk Afdeling
  • KAS Herlev
  • Sygehus Vendsyssel Hjorring
  • Bispebjerg Hospital
  • Roskilde Amts Sygehus Koge
  • Medicinsk Afdeling Kolding Sygehus
  • Reinier de Graaf Gasthuis
  • Catharina Ziekenhuis
  • Medisch Spectrum Twente
  • University Medical Center Groningen (UMCG)
  • Trial sectie Cardiologie
  • Academisch Ziekenhuis Maastricht
  • Stichting Sint Antonius Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recurrence of AF/AFL or withdrawal
Improvement in AF symptoms

Full Information

First Posted
December 20, 2005
Last Updated
December 17, 2008
Sponsor
Advanz Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00267930
Brief Title
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

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Advanz Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
AFib, AF

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d
Arm Title
2
Arm Type
Experimental
Arm Description
Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d
Arm Title
3
Arm Type
Experimental
Arm Description
Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d
Intervention Type
Drug
Intervention Name(s)
Vernakalant (oral)
Other Intervention Name(s)
RSD1235-SR
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Recurrence of AF/AFL or withdrawal
Time Frame
Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing
Title
Improvement in AF symptoms
Time Frame
Time to improvement in AF symptoms within Day 28 of dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Beatch, PhD
Organizational Affiliation
Advanz Pharma
Official's Role
Study Director
Facility Information:
Facility Name
The Heart Center, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Cardiovascular Consultants Medical Group, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Penn State Heart & Vascular Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Aalborg Sygehus Syd
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus Sygehus Kardiologisk Afd. A
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
KAS Gentofte Kardiologisk Afdeling
City
Hellerup
Country
Denmark
Facility Name
KAS Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Sygehus Vendsyssel Hjorring
City
Hjorring
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Kobenhavn
Country
Denmark
Facility Name
Roskilde Amts Sygehus Koge
City
Koge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Medicinsk Afdeling Kolding Sygehus
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Reinier de Graaf Gasthuis
City
Delft
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
University Medical Center Groningen (UMCG)
City
Groningen
Country
Netherlands
Facility Name
Trial sectie Cardiologie
City
Heerlen
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
Country
Netherlands
Facility Name
Stichting Sint Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.cardiome.com
Description
Related Info

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

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