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Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation (ACT I)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vernakalant Injection 20 mg/mL
Sponsored by
Advanz Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, RSD1235, Atrial fibrillation of 3 hours to 7 days duration., Atrial fibrillation of 3 hours to 45 days duration.

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older;
  • Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days.
  • Have adequate anticoagulant therapy.

Exclusion Criteria:

  • Have a QRS > 0.14 seconds unless patient has pacemaker or uncorrected QT > 0.440 seconds as measured on a 12-lead ECG.
  • Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
  • Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.

Sites / Locations

  • University of California
  • Regional Cardiology Associates
  • Florida Heart Institute
  • James Haley VA Hospital
  • Cardiac Arrhythmia Service, Massachusetts General Hospital
  • Thoracic and Cardiovascular Institute
  • Oregon Health & Science University
  • Main Line Health Heart Center
  • Medical College of Virginia
  • McGuire VA Medical Center
  • Marshfield Clinic
  • Heart Health Institute, Rockyview General Hospital
  • University of Calgary
  • University of Alberta Hospital
  • Cardiac Arrhythmia Trials
  • Hamilton Health Sciences, Hamilton General Hospital
  • Ottawa Hospitals (Civic & General)
  • Sunnybrook Health Sciences Centre, Emergency Medicine Research Program
  • Institut de Cardiologie de Montreal
  • Hopital Notre-Dame du CHUM
  • CHUM-Hotel-Dieu de Montreal
  • Institute de Cardiologie de Quebec, Hopital Laval
  • Centre Hospitalier LeGardeur
  • Aalborg University
  • Århus Amtssygehus, Med. kardiologisk
  • Centralsygehuset Esbjerg Varde
  • Fredericia Sygehus
  • Frederikssund Sygehus
  • Glostrup Amtssygehus
  • Haderslev Sygehus, Kardiologisk Laboratorium
  • Gentofte Amtssygehus
  • Helsingor Sygehus, Kardiovaskulært
  • Herlev Amtssygehus, Kardiologisk
  • Hillerod Sygehus, Medicinsk
  • Sygehus Vendsyssel Hjorring
  • Holstebro centralsygehus
  • Horsens Sygehus
  • Hvidovre Hospital, Kardiologisk
  • Amager Hospital, Med. Center
  • H:S Bispebjerg Hospital
  • Roskilde Amts Sygehus Køge
  • Kolding Sygehus, Kardiologisk ambulatorium
  • Sygehus Fyn Svendborg
  • Universitetssjukhuset MAS
  • Universitetssjukhuset, Molndal
  • Universityetssjukhuset, Orebro
  • Danderyds sjukhus
  • Akademiska Sjukhuset, Uppsala
  • Centrallasarettet, Vasteras

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Atrial fibrillation (AF) duration of 3 hours to 7 days.

AF duration of >7 days to <45 days

Outcomes

Primary Outcome Measures

To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.

Secondary Outcome Measures

To assess the safety of RSD1235 in this patient population.

Full Information

First Posted
May 1, 2007
Last Updated
March 31, 2008
Sponsor
Advanz Pharma
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00468767
Brief Title
Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
Acronym
ACT I
Official Title
A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Advanz Pharma
Collaborators
Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Detailed Description
There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and atrial flutter in the United States (Heart Disease & Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure. This Phase III trial is Cardiome's first pivotal study with RSD1235. The study seeks to confirm the findings of the Phase II proof-of-concept through demonstration of RSD1235's abilities to convert AF to sinus rhythm. The patient population will include recent onset AF (AF duration of 3 hours to 7 days) and patients with longer AF duration. This is a double-blind, placebo-controlled, randomized study in patients with AF; stratification will be based on duration of AF. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, RSD1235, Atrial fibrillation of 3 hours to 7 days duration., Atrial fibrillation of 3 hours to 45 days duration.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Atrial fibrillation (AF) duration of 3 hours to 7 days.
Arm Title
2
Arm Type
Experimental
Arm Description
AF duration of >7 days to <45 days
Intervention Type
Drug
Intervention Name(s)
Vernakalant Injection 20 mg/mL
Other Intervention Name(s)
RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)
Primary Outcome Measure Information:
Title
To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Time Frame
The proportion of patients with atrial fibrillation (AF) of 3 hours to 7 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.
Secondary Outcome Measure Information:
Title
To assess the safety of RSD1235 in this patient population.
Time Frame
The proportion of patients with AF of 3 hours to 45 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older; Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days. Have adequate anticoagulant therapy. Exclusion Criteria: Have a QRS > 0.14 seconds unless patient has pacemaker or uncorrected QT > 0.440 seconds as measured on a 12-lead ECG. Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety. Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila Grant, MBA
Organizational Affiliation
Advanz Pharma
Official's Role
Study Director
Facility Information:
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Florida Heart Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
James Haley VA Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Cardiac Arrhythmia Service, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Thoracic and Cardiovascular Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Main Line Health Heart Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Heart Health Institute, Rockyview General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E 7C5
Country
Canada
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Cardiac Arrhythmia Trials
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Hamilton Health Sciences, Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Ottawa Hospitals (Civic & General)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre, Emergency Medicine Research Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Institut de Cardiologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Hopital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
CHUM-Hotel-Dieu de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Institute de Cardiologie de Quebec, Hopital Laval
City
Ste Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Centre Hospitalier LeGardeur
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Facility Name
Aalborg University
City
Aalborg
Country
Denmark
Facility Name
Århus Amtssygehus, Med. kardiologisk
City
Arhus
Country
Denmark
Facility Name
Centralsygehuset Esbjerg Varde
City
Esbjerg
Country
Denmark
Facility Name
Fredericia Sygehus
City
Fredericia
Country
Denmark
Facility Name
Frederikssund Sygehus
City
Frederikssund
Country
Denmark
Facility Name
Glostrup Amtssygehus
City
Glostrup
Country
Denmark
Facility Name
Haderslev Sygehus, Kardiologisk Laboratorium
City
Haderslev
Country
Denmark
Facility Name
Gentofte Amtssygehus
City
Hellerup
Country
Denmark
Facility Name
Helsingor Sygehus, Kardiovaskulært
City
Helsingor
Country
Denmark
Facility Name
Herlev Amtssygehus, Kardiologisk
City
Herlev
Country
Denmark
Facility Name
Hillerod Sygehus, Medicinsk
City
Hillerod
Country
Denmark
Facility Name
Sygehus Vendsyssel Hjorring
City
Hjorring
Country
Denmark
Facility Name
Holstebro centralsygehus
City
Holstebro
Country
Denmark
Facility Name
Horsens Sygehus
City
Horsens
Country
Denmark
Facility Name
Hvidovre Hospital, Kardiologisk
City
Hvidovre
Country
Denmark
Facility Name
Amager Hospital, Med. Center
City
Kobenhavn
Country
Denmark
Facility Name
H:S Bispebjerg Hospital
City
Kobenhavn
Country
Denmark
Facility Name
Roskilde Amts Sygehus Køge
City
Koge
Country
Denmark
Facility Name
Kolding Sygehus, Kardiologisk ambulatorium
City
Kolding
Country
Denmark
Facility Name
Sygehus Fyn Svendborg
City
Svendborg
Country
Denmark
Facility Name
Universitetssjukhuset MAS
City
Malmo
Country
Sweden
Facility Name
Universitetssjukhuset, Molndal
City
Molndal
Country
Sweden
Facility Name
Universityetssjukhuset, Orebro
City
Orebro
Country
Sweden
Facility Name
Danderyds sjukhus
City
Stockholm
Country
Sweden
Facility Name
Akademiska Sjukhuset, Uppsala
City
Uppsala
Country
Sweden
Facility Name
Centrallasarettet, Vasteras
City
Vasteras
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21175515
Citation
Stiell IG, Dickinson G, Butterfield NN, Clement CM, Perry JJ, Vaillancourt C, Calder LA. Vernakalant hydrochloride: A novel atrial-selective agent for the cardioversion of recent-onset atrial fibrillation in the emergency department. Acad Emerg Med. 2010 Nov;17(11):1175-82. doi: 10.1111/j.1553-2712.2010.00915.x. Erratum In: Acad Emerg Med. 2011 Feb;18(2):224.
Results Reference
derived
PubMed Identifier
18332267
Citation
Roy D, Pratt CM, Torp-Pedersen C, Wyse DG, Toft E, Juul-Moller S, Nielsen T, Rasmussen SL, Stiell IG, Coutu B, Ip JH, Pritchett EL, Camm AJ; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial. Circulation. 2008 Mar 25;117(12):1518-25. doi: 10.1161/CIRCULATIONAHA.107.723866. Epub 2008 Mar 10.
Results Reference
derived

Learn more about this trial

Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation

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