Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation - Full Text View

Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation (ACT 4)

This study has been completed.

First Received on January 24, 2006. Last Updated on April 1, 2008 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborator:	Cardiome Pharma
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00281554

Purpose

This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: RSD1235	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects 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 Astellas Pharma Inc:

Primary Outcome Measures:

Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute [ Time Frame: Infusion plus 1.5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate safety [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment:	254
Study Start Date:	October 2005
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RSD1235 IV Other Names: vernakalant Kynapid

Eligibility

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

Criteria

Inclusion Criteria:

Subject must have symptomatic AF
Subject must have adequate anticoagulant therapy

Exclusion Criteria:

Subject may not have Class IV congestive heart failure.
Subject may not have uncorrected electrolyte imbalance.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281554

Show 40 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Cardiome Pharma

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided by Astellas Pharma Inc

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.

Stiell IG, Roos JS, Kavanagh KM, Dickinson G. A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm. Am Heart J. 2010 Jun;159(6):1095-101.

Responsible Party:	Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier:	NCT00281554 History of Changes
Other Study ID Numbers:	05-7-012
Study First Received:	January 24, 2006
Last Updated:	April 1, 2008
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Sweden: Medical Products Agency; Denmark: Danish Medicines Agency; South Africa: Medicines Control Council

Keywords provided by Astellas Pharma Inc:

Investigational Therapies
Atrial Fibrillation
Treatment Efficacy

Treatment Effectiveness
Safety
RSD1235

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012