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

Atrial Flutter Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476112
• Other study ID #: 1235-0703B
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 18, 2007
• Last updated: March 31, 2008
• Start date: August 2003
• Est. completion date: September 2004

Study information

• Verified date: March 2008
• Source: Cardiome Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaDenmark: Danish Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Drug:
• Vernakalant Injection 20 mg/mL

Locations

Country	Name	City	State
Canada	Heart Health Institute, Rockyview General Hospital	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences, Hamilton General Hospital	Hamilton	Ontario
Canada	CHUM-Hotel-Dieu de Montreal	Montreal	Quebec
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	Institut de Cardiologie de Montreal	Montreal	Quebec
Canada	Ottawa Hospitals (Civic & General)	Ottawa	Ontario
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
Sweden	Universitetssjukhuset MAS	Malmo
Sweden	Centrallasarettet, Vasteras	Vasteras
United States	Thoracic and Cardiovascular Institute	Lansing	Michigan
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Medical College of Virginia	Richmond	Virginia
United States	Regional Cardiology Associates	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Cardiome Pharma	Astellas Pharma US, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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.	No
Secondary	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.		Treatment-induced reduction of the ventricular response rate within 50 minutes of first exposure to treatment for patient with atrial flutter.	No