Clinical trial NCT00713401: Safety Study of Tecadenoson to Treat Atrial Fibrillation
Official title: An Open-Label, Sequential-Group, Dose-Escalation Study To Evaluate The Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Tecadenoson Alone and in Combination With a Beta-Blocker in Adults With Rapid Atrial Fibrillation (CVT 4129)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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 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 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

Primary outcomes:
measure: Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
timeFrame: Baseline to Day 7
Secondary outcomes:
measure: Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram
timeFrame: Baseline to Day 7
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: CV Therapeutics, Inc.
state: California
Study officials:
References:
citation: Corino VD, Holmqvist F, Mainardi LT, Platonov PG. Beta-blockade and A1-adenosine receptor agonist effects on atrial fibrillatory rate and atrioventricular conduction in patients with atrial fibrillation. Europace. 2014 Apr;16(4):587-94. doi: 10.1093/europace/eut251. Epub 2013 Aug 29.