A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
Scene 2
A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
1 other identifier
interventional
60
4 countries
24
Brief Summary
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2003
Shorter than P25 for phase_2
24 active sites
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
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedApril 2, 2008
March 1, 2008
1.1 years
May 18, 2007
March 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate the effectiveness of RSD1235 in the conversion of AFL to sinus rhythm. Treatment will be considered successful if there is treatment-induced conversion of AFL to sinus rhythm for a minimum of 1 minute duration by Hour 1.5.
The proportion of patients with atrial flutter who have treatment-induced conversion of atrial flutter to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.
Secondary Outcomes (1)
To assess the safety of RSD1235 in this patient population and to assess the efficacy of RSD1235 in lowering the ventricular response rate in patients with AFL.
Treatment-induced reduction of the ventricular response rate within 50 minutes of first exposure to treatment for patient with atrial flutter.
Study Arms (1)
1
EXPERIMENTALAtrial flutter duration of 3 hours to \<45 days
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older.
- Have an atrial arrhythmia with dysrhythmic symptoms that has been sustained for greater than 3 hours and up to 45 days.
- Have adequate anticoagulant therapy.
You may not qualify if:
- Have a QRS \> 0.14 s unless patient has pacemaker or uncorrected QT \> 0.440 seconds as measured on a 12-lead ECG.
- Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to enrollment, or have previously received RSD1235.
- Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
- Have received IV Class I or Class III antiarrhythmic drugs or IV amiodarone within 24 hours prior to dosing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanz Pharmalead
- Astellas Pharma US, Inc.collaborator
Study Sites (24)
Regional Cardiology Associates
Sacramento, California, 95819, United States
Thoracic and Cardiovascular Institute
Lansing, Michigan, 48910, United States
Medical College of Virginia
Richmond, Virginia, 23219, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Heart Health Institute, Rockyview General Hospital
Calgary, Alberta, T2E 7C5, Canada
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Hamilton Health Sciences, Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Ottawa Hospitals (Civic & General)
Ottawa, Ontario, K1Y 4E9, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
CHUM-Hotel-Dieu de Montreal
Montreal, Quebec, H2W 1T8, Canada
Aalborg University
Aalborg, Denmark
H:S Bispebjerg Hospital
Copenhagen, Denmark
Centralsygehuset Esbjerg Varde
Esbjerg, Denmark
Glostrup Amtssygehus
Glostrup Municipality, Denmark
Gentofte Amtssygehus
Hellerup, Denmark
Herlev Amtssygehus, Kardiologisk
Herlev, Denmark
Sygehus Vendsyssel Hjorring
Hjørring, Denmark
Holstebro centralsygehus
Holstebro, Denmark
Hvidovre Hospital, Kardiologisk
Hvidovre, Denmark
Universitetssjukhuset MAS
Malmo, Sweden
Centrallasarettet, Vasteras
Västerås, Sweden
Related Publications (1)
Camm AJ, Toft E, Torp-Pedersen C, Vijayaraman P, Juul-Moller S, Ip J, Beatch GN, Dickinson G, Wyse DG; Scene 2 Investigators. Efficacy and safety of vernakalant in patients with atrial flutter: a randomized, double-blind, placebo-controlled trial. Europace. 2012 Jun;14(6):804-9. doi: 10.1093/europace/eur416. Epub 2012 Jan 29.
PMID: 22291438DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sheila Grant, MBA
Advanz Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 21, 2007
Study Start
August 1, 2003
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
April 2, 2008
Record last verified: 2008-03