Safety Study of Tecadenoson to Treat Atrial Fibrillation
NCT ID: NCT00713401
Last Updated: 2014-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2008-02-29
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A
Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion
Tecadenoson
Tecadenoson administered intravenously (i.v.)
Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Cohort B
Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion
Tecadenoson
Tecadenoson administered intravenously (i.v.)
Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Cohort C
Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion
Tecadenoson
Tecadenoson administered intravenously (i.v.)
Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Cohort D
Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion
Tecadenoson
Tecadenoson administered intravenously (i.v.)
Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Cohort E
Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion
Tecadenoson
Tecadenoson administered intravenously (i.v.)
Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Interventions
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Tecadenoson
Tecadenoson administered intravenously (i.v.)
Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Locations
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CV Therapeutics, Inc.
Palo Alto, California, United States
Countries
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References
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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.
Other Identifiers
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CVT 4129
Identifier Type: -
Identifier Source: org_study_id
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