Expired Study
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Palo Alto, California 94304


Purpose:

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 control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic effects when given alone and in combination with beta-blocker (esmolol).


Criteria:

Inclusion Criteria: - Have a diagnosis of atrial fibrillation in need of treatment for rate control - Be able and willing to abstain from any antiarrhythmics, including 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 Criteria: - 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


NCT ID:

NCT00713401


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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