A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter (Scene 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00476112
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : April 2, 2008
Astellas Pharma US, Inc.
Information provided by:
Cardiome Pharma

Brief Summary:
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.

Condition or disease Intervention/treatment Phase
Atrial Flutter Drug: Vernakalant Injection 20 mg/mL Phase 2 Phase 3

Detailed Description:

There are approximately 2 million reported prevalent cases of atrial fibrillation and atrial flutter (AFL) in the United States (Heart Disease & Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. AF/AFL is usually associated with age, and general physical condition, rather than with a specific cardiac event, as is often the case with ventricular arrhythmia. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.

This Phase II/III trial is Cardiome's first study with RSD1235 for the treatment of atrial flutter. The study seeks to demonstrate RSD1235's abilities to convert AFL to sinus rhythm. The patient population will have atrial flutter of duration greater than 3 hours and less than or equal to 45 days.

This is a double-blind, placebo-controlled, randomized study in patients with AFL; stratification will be based on duration of AFL. 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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
Study Start Date : August 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Arm Intervention/treatment
Experimental: 1
Atrial flutter duration of 3 hours 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 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. [ Time Frame: 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 Outcome Measures :
  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. [ Time Frame: Treatment-induced reduction of the ventricular response rate within 50 minutes of first exposure to treatment for patient with atrial flutter. ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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.

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 identifier (NCT number): NCT00476112

United States, California
Regional Cardiology Associates
Sacramento, California, United States, 95819
United States, Michigan
Thoracic and Cardiovascular Institute
Lansing, Michigan, United States, 48910
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, Ontario
Hamilton Health Sciences, Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Ottawa Hospitals (Civic & General)
Ottawa, Ontario, Canada, K1Y 4E9
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
Aalborg University
Aalborg, Denmark
Centralsygehuset Esbjerg Varde
Esbjerg, Denmark
Glostrup Amtssygehus
Glostrup, Denmark
Gentofte Amtssygehus
Hellerup, Denmark
Herlev Amtssygehus, Kardiologisk
Herlev, Denmark
Sygehus Vendsyssel Hjorring
Hjorring, Denmark
Holstebro centralsygehus
Holstebro, Denmark
Hvidovre Hospital, Kardiologisk
Hvidovre, Denmark
H:S Bispebjerg Hospital
Kobenhavn, Denmark
Universitetssjukhuset MAS
Malmo, Sweden
Centrallasarettet, Vasteras
Vasteras, Sweden
Sponsors and Collaborators
Cardiome Pharma
Astellas Pharma US, Inc.
Study Director: Sheila Grant, MBA Cardiome Pharma

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sheila Grant, VP of Product Development, Vernakalant, Cardiome Pharma Corp. Identifier: NCT00476112     History of Changes
Other Study ID Numbers: 1235-0703B
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: April 2, 2008
Last Verified: March 2008

Keywords provided by Cardiome Pharma:
Atrial flutter

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes