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View Clinical Trial (Medical Research Study)
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A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF) - NCT00989001-55455 (Clinical Trial 368156)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy368156.aspx
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| City: |
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Minneapolis |
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State:
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MN |
| Zip Code: |
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55455 |
| Conditions: |
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Atrial Fibrillation |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Minneapolis, MN 55455
United States
Primary Contact:
Astellas Pharma Global Development
Email: clintrials.info@us.astellas.com
Phone: 800-888-7704 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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