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

March 31, 2008 updated by: Advanz Pharma

A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Atrial fibrillation (AF) duration of 3 hours to 7 days.
Drug: Vernakalant Injection 20 mg/mL
Other Names:
  • RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)
Experimental: 2
AF duration of >7 days to <45 days
Drug: Vernakalant Injection 20 mg/mL
Other Names:
  • RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanz Pharma

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Study Director: Sheila Grant, MBA, Advanz Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

May 1, 2007

First Submitted That Met QC Criteria

May 2, 2007

First Posted (Estimate)

May 3, 2007

Study Record Updates

Last Update Posted (Estimate)

April 2, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1235-0703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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