Safety Study of Tecadenoson to Treat Atrial Fibrillation
Completed · Phase 2
Conditions studied: Atrial Fibrillation
In brief
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).
Key facts
- Study ID
- NCT00713401
- Run by
- Gilead Sciences
- People needed
- 21
- Starts
- 2008-02-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2014-03-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- CV Therapeutics, Inc. — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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