A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter (Scene 2)
March 31, 2008 updated by: Advanz Pharma
A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
60
Phase
- Phase 2
- 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
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- University Of Calgary
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Calgary, Alberta, Canada, T2E 7C5
- Heart Health Institute, Rockyview General Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences, Hamilton General Hospital
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Ottawa, Ontario, Canada, K1Y 4E9
- Ottawa Hospitals (Civic & General)
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Quebec
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Montreal, Quebec, Canada, H1T 1C8
- Institut de Cardiologie de Montreal
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Montreal, Quebec, Canada, H2L 4M1
- Hopital Notre-Dame du CHUM
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Montreal, Quebec, Canada, H2W 1T8
- CHUM-Hotel-Dieu de Montreal
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Aalborg, Denmark
- Aalborg University
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Esbjerg, Denmark
- Centralsygehuset Esbjerg Varde
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Glostrup, Denmark
- Glostrup Amtssygehus
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Hellerup, Denmark
- Gentofte Amtssygehus
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Herlev, Denmark
- Herlev Amtssygehus, Kardiologisk
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Hjorring, Denmark
- Sygehus Vendsyssel Hjorring
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Holstebro, Denmark
- Holstebro centralsygehus
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Hvidovre, Denmark
- Hvidovre Hospital, Kardiologisk
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Kobenhavn, Denmark
- H:S Bispebjerg Hospital
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Malmo, Sweden
- Universitetssjukhuset MAS
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Vasteras, Sweden
- Centrallasarettet, Vasteras
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California
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Sacramento, California, United States, 95819
- Regional Cardiology Associates
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Michigan
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Lansing, Michigan, United States, 48910
- Thoracic and Cardiovascular Institute
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Virginia
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Richmond, Virginia, United States, 23249
- McGuire VA Medical Center
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Richmond, Virginia, United States, 23219
- Medical College of Virginia
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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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 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.
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 |
|---|---|
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Experimental: 1
Atrial flutter duration of 3 hours to <45 days
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
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Treatment-induced reduction of the ventricular response rate within 50 minutes of first exposure to treatment for patient with atrial flutter.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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)
September 1, 2004
Study Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
May 18, 2007
First Submitted That Met QC Criteria
May 18, 2007
First Posted (Estimate)
May 21, 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
- 1235-0703B
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.