Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation - Full Text View

Sponsor:	Cardiome Pharma
Collaborator:	Astellas Pharma US, Inc.
Information provided by:	Cardiome Pharma
ClinicalTrials.gov Identifier:	NCT00468767

Purpose

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

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Vernakalant Injection 20 mg/mL	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: RSD 1235

U.S. FDA Resources

Further study details as provided by Cardiome Pharma:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Enrollment:	356
Study Start Date:	August 2003
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Atrial fibrillation (AF) duration of 3 hours to 7 days.	Drug: Vernakalant Injection 20 mg/mL Other Name: RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)
Experimental: 2 AF duration of >7 days 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 (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.

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468767

Show 49 Study Locations

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):

Stiell IG, Dickinson G, Butterfield NN, Clement CM, Perry JJ, Vaillancourt C, Calder LA. Vernakalant hydrochloride: A NovelAtrial-selective agent for the cardioversionof recent-onset atrial fibrillation in the emergency department. Acad Emerg Med. 2010 Nov;17(11):1175-82.

Roy D, Pratt CM, Torp-Pedersen C, Wyse DG, Toft E, Juul-Moller S, Nielsen T, Rasmussen SL, Stiell IG, Coutu B, Ip JH, Pritchett EL, Camm AJ; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial. Circulation. 2008 Mar 25;117(12):1518-25. Epub 2008 Mar 10.

Responsible Party:	Sheila Grant, VP of Product Development, Vernakalant, Cardiome Pharma Corp.
ClinicalTrials.gov Identifier:	NCT00468767 History of Changes
Other Study ID Numbers:	1235-0703
Study First Received:	May 1, 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 fibrillation
RSD1235
Atrial fibrillation of 3 hours to 7 days duration.
Atrial fibrillation of 3 hours to 45 days duration.

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012