A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF) - Full Text View

Sponsor:	Astellas Pharma Inc
Collaborator:	Cardiome Pharma
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00989001

Purpose

The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Vernakalant Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients With Recent Onset Symptomatic 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:

Composite of occurrences of hypotension, ventricular arrhythmias and death verified by the Clinical Events Committee [ Time Frame: Occurring within the first two hours after start of study treatment ] [ Designated as safety issue: Yes ]
Successful conversion to sinus rhythm (SR) for at least one minute [ Time Frame: Occurring within 90 minutes of first exposure to study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from first exposure to study treatment to conversion of AF to SR [ Time Frame: Occurring within 90 minutes after study treatment ] [ Designated as safety issue: No ]
Proportion of subjects reporting no symptoms [ Time Frame: Occurring 90 minutes after first exposure to study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	470
Study Start Date:	October 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vernakalant	Drug: Vernakalant Injection Other Name: RSD1235
Placebo Comparator: Placebo	Drug: Placebo Injection

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females must be not pregnant or nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 30 days post study treatment
Subject must have recent onset (> 3 hours to <= 7 days) symptomatic AF to be best managed by acute conversion to SR
Subject must have adequate anticoagulant therapy
Subject must have systolic blood pressure (SBP) above 90 mmHg and less than 160 mmHg and diastolic blood pressure (DBP) less than 95 mmHg at screening and baseline
Subject must have a body weight between 45 and 136 kg, inclusive (99 and 300 lbs)

Exclusion Criteria:

Subject has a history of heart failure or documentation of left ventricular dysfunction
Subject has known or suspected prolonged QT or uncorrected QT interval of > 0.440 sec
Subject has symptomatic bradycardia or ventricular rate less than 50 bpm at Screening, unless controlled by a pacemaker
Subject has bradycardia (heart rate less than 50 bpm) or hypotension (SBP less that 90 mmHg) after receiving a loading, bolus dose, or sustained infusion of any rate control medication during Screening
Subject has a QRS interval > 0.14 sec., unless subject has a pacemaker
Subject had a myocardial infarction (MI), acute coronary syndrome, cardiac surgery (including percutaneous transluminal coronary angioplasty (PTCA) or stent placement), within 30 days prior to enrollment or subject has evidence of new ischemic changes on Screening 12-lead ECG
Subject has troponin I or T levels beyond the upper limit of normal for the local lab
Subject has significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
Subject has failed electrical cardioversion for AF at anytime
Subject has failed pharmacologic conversion with an intravenous Class I or Class III antiarrhythmic drug for this episode of AF
Subject has any known reversible causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, acute pericarditis or hypoxemia
Subject has uncorrected electrolyte imbalance
Subject has clinical evidence of digoxin toxicity
Subject has a history of clinically significant illness (e.g. neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, endocrine, hematological, or psychiatric), medical condition or laboratory abnormality within 4 weeks prior to Screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989001

Show 108 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Cardiome Pharma

Investigators

Study Director:

Senior Medical Director

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00989001 History of Changes
Other Study ID Numbers:	6517-CL-0020
Study First Received:	October 1, 2009
Last Updated:	March 23, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Mexico: Federal Commission for Sanitary Risks Protection; Peru: Instituto Nacional de Salud; Chile: Instituto de Salud Publica de Chile; South Africa: Medicines Control Council; Israel: Ministry of Health; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: The Central Register of Clinical Trials

Keywords provided by Astellas Pharma Inc:

Atrial Fibrillation
RSD1235
Vernakalant
conversion

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012