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Trial record 1 of 14 for:    vernakalant AND atrial fibrillation
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Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation (ACT I)

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ClinicalTrials.gov Identifier: NCT00468767
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : April 2, 2008
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Cardiome Pharma

Brief Summary:
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Vernakalant Injection 20 mg/mL Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2003
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Atrial fibrillation (AF) duration of 3 hours to 7 days.
Drug: Vernakalant Injection 20 mg/mL
Other Name: RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)

Experimental: 2
AF duration of >7 days to <45 days
Drug: Vernakalant Injection 20 mg/mL
Other Name: RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468767


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Locations
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United States, California
University of California
Los Angeles, California, United States, 90073
Regional Cardiology Associates
Sacramento, California, United States, 95819
United States, Florida
Florida Heart Institute
Orlando, Florida, United States, 32803
James Haley VA Hospital
Tampa, Florida, United States, 33612
United States, Massachusetts
Cardiac Arrhythmia Service, Massachusetts General Hospital
Boston, Massachusetts, United States, 02459
United States, Michigan
Thoracic and Cardiovascular Institute
Lansing, Michigan, United States, 48910
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Main Line Health Heart Center
Wynnewood, Pennsylvania, United States, 19096
United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States, 23219
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Canada, Alberta
Heart Health Institute, Rockyview General Hospital
Calgary, Alberta, Canada, T2E 7C5
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Hamilton Health Sciences, Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Ottawa Hospitals (Civic & General)
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook Health Sciences Centre, Emergency Medicine Research Program
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada, H1T 1C8
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
CHUM-Hotel-Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8
Institute de Cardiologie de Quebec, Hopital Laval
Ste Foy, Quebec, Canada, G1V 4G5
Centre Hospitalier LeGardeur
Terrebonne, Quebec, Canada, J6V 2H2
Denmark
Aalborg University
Aalborg, Denmark
Århus Amtssygehus, Med. kardiologisk
Arhus, Denmark
Centralsygehuset Esbjerg Varde
Esbjerg, Denmark
Fredericia Sygehus
Fredericia, Denmark
Frederikssund Sygehus
Frederikssund, Denmark
Glostrup Amtssygehus
Glostrup, Denmark
Haderslev Sygehus, Kardiologisk Laboratorium
Haderslev, Denmark
Gentofte Amtssygehus
Hellerup, Denmark
Helsingor Sygehus, Kardiovaskulært
Helsingor, Denmark
Herlev Amtssygehus, Kardiologisk
Herlev, Denmark
Hillerod Sygehus, Medicinsk
Hillerod, Denmark
Sygehus Vendsyssel Hjorring
Hjorring, Denmark
Holstebro centralsygehus
Holstebro, Denmark
Horsens Sygehus
Horsens, Denmark
Hvidovre Hospital, Kardiologisk
Hvidovre, Denmark
Amager Hospital, Med. Center
Kobenhavn, Denmark
H:S Bispebjerg Hospital
Kobenhavn, Denmark
Roskilde Amts Sygehus Køge
Koge, Denmark
Kolding Sygehus, Kardiologisk ambulatorium
Kolding, Denmark
Sygehus Fyn Svendborg
Svendborg, Denmark
Sweden
Universitetssjukhuset MAS
Malmo, Sweden
Universitetssjukhuset, Molndal
Molndal, Sweden
Universityetssjukhuset, Orebro
Orebro, Sweden
Danderyds sjukhus
Stockholm, Sweden
Akademiska Sjukhuset, Uppsala
Uppsala, Sweden
Centrallasarettet, Vasteras
Vasteras, Sweden
Sponsors and Collaborators
Cardiome Pharma
Astellas Pharma US, Inc.
Investigators
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Study Director: Sheila Grant, MBA Cardiome Pharma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sheila Grant, VP of Product Development, Vernakalant, Cardiome Pharma Corp.
ClinicalTrials.gov Identifier: NCT00468767     History of Changes
Other Study ID Numbers: 1235-0703
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: April 2, 2008
Last Verified: March 2008
Keywords provided by Cardiome Pharma:
Atrial fibrillation
RSD1235
Atrial fibrillation of 3 hours to 7 days duration.
Atrial fibrillation of 3 hours to 45 days duration.
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes