Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

This study has been completed.

First Received on June 26, 2005. Last Updated on March 29, 2008 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborator:	Cardiome Pharma
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00115791

Purpose

The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.

Condition	Intervention	Phase
Atrial Flutter Atrial Fibrillation	Drug: RSD1235 Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

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:

To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm [ Time Frame: Infusion plus 1.5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the time taken from exposure to first treatment to first conversion to sinus rhythm [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment:	276
Study Start Date:	June 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RSD1235 IV Other Names: vernakalant Kynapid
Placebo Comparator: 2	Drug: placebo IV

Eligibility

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

Criteria

Inclusion Criteria:

Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days

Exclusion Criteria:

Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115791

Show 54 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

Responsible Party:	Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier:	NCT00115791 History of Changes
Other Study ID Numbers:	04-7-010, Cardiome 1235-0504
Study First Received:	June 26, 2005
Last Updated:	March 29, 2008
Health Authority:	United States: Food and Drug Administration; Sweden: Medical Products Agency; Denmark: Danish Medicines Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Chile: Instituto de Salud Publica de Chile; Canada: Health Canada; Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Astellas Pharma Inc:

Atrial Flutters
Atrial Fibrillations
RSD1235

Additional relevant MeSH terms:

Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012