Status:
COMPLETED
Safety Study of Tecadenoson to Treat Atrial Fibrillation
Lead Sponsor:
Gilead Sciences
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels when given alone and in combination with a beta-blocker (esmolol) in patients with atrial fibrillation to co...
Eligibility Criteria
Inclusion
- Have a diagnosis of atrial fibrillation in need of treatment for rate control
- Be able and willing to abstain from any antiarrhythmics, including atrioventricular (AV) nodal blocking agents (except for esmolol per protocol), from no later than 8:00 p.m. on the day prior to dosing until completion of the last dose period assessment
- Be able and willing to abstain from xanthine- or chocolate-containing foods, beverages, and medications
- Females must be post-menopausal or sterilized; or if of childbearing potential, must not be breastfeeding and must have a negative pregnancy test at screening and no intention of becoming pregnant during the course of the study. Males and females must be using adequate contraception during the study.
Exclusion
- Have a known accessory pathway
- Have active myocardial ischemia or recent acute coronary syndrome
- Have acute or overt heart failure, bradycardia, heart block greater than first degree, or cardiogenic shock
- Have allergies or contraindications to treatment with esmolol or aminophylline, or any of their constituents
- Have a supine cuff systolic blood pressure \< 90 mm Hg
- Be undergoing treatment with theophylline/aminophylline preparations, Trental® (pentoxifylline), or carbamazepine
- Have asthma or other reactive airways disease currently on-treatment
- Have a history of an active or chronic pancreatic disease or clinically significant increased levels of serum amylase or lipase
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00713401
Start Date
February 1 2008
End Date
July 1 2008
Last Update
March 11 2014
Active Locations (1)
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1
CV Therapeutics, Inc.
Palo Alto, California, United States, 94304