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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT00476112
First received: May 18, 2007
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Cardiome Pharma:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476112

Locations
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
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Medical College of Virginia
Richmond, Virginia, United States, 23219
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
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada, H1T 1C8
CHUM-Hotel-Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8
Denmark
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
Sweden
Universitetssjukhuset MAS
Malmo, Sweden
Centrallasarettet, Vasteras
Vasteras, Sweden
Sponsors and Collaborators
Cardiome Pharma
Astellas Pharma US, Inc.
Investigators
Study Director: Sheila Grant, MBA Cardiome Pharma
  More Information

No publications provided by Cardiome Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheila Grant, VP of Product Development, Vernakalant, Cardiome Pharma Corp.
ClinicalTrials.gov Identifier: NCT00476112     History of Changes
Other Study ID Numbers: 1235-0703B
Study First Received: May 18, 2007
Last Updated: March 31, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency

Keywords provided by Cardiome Pharma:
Atrial flutter
RSD1235

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

ClinicalTrials.gov processed this record on October 23, 2014