Safety Study of Tecadenoson to Treat Atrial Fibrillation

This study has been completed.

Sponsor:

Information provided by:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT00713401

First received: July 9, 2008

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 9, 2008
Last Updated Date	March 23, 2011
Start Date ^ICMJE	February 2008
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 10, 2008)	Determine the tolerability and safety of tecadenoson. [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00713401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 10, 2008)	Evaluate effect of tecadenoson alone and in combination with esmolol on R-R interval and ventricular rate. [ Time Frame: 7 Day ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety Study of Tecadenoson to Treat Atrial Fibrillation
Official Title ^ICMJE	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)
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Atrial Fibrillation
Intervention ^ICMJE	Drug: Tecadenoson Period 1: 75 mcg, IV bolus. Period 2: 75 mcg, IV bolus + esmolol low dose infusion. Other Name: CVT-510 Drug: Tecadenoson Period 1: 150 mcg, IV bolus. Period 2: 150 mcg, IV bolus + esmolol low dose infusion. Other Name: CVT-510 Drug: Tecadenoson Period 1: 300 mcg, IV bolus. Period 2: 300 mcg, IV bolus + esmolol low dose infusion. Other Name: CVT-510 Drug: Tecadenoson Period 1: 75 mcg, IV bolus. Period 2: 75 mcg, IV bolus + esmolol high dose infusion. Other Name: CVT-510 Drug: Tecadenoson Period 1: 150 or 300 mcg, IV bolus. Period 2: 150 or 300 mcg, IV bolus + esmolol high dose infusion. Other Name: CVT-510
Study Arm (s)	Experimental: A Tecadenoson Intervention: Drug: Tecadenoson Experimental: B Tecadenoson Intervention: Drug: Tecadenoson Experimental: C Tecadenoson Intervention: Drug: Tecadenoson Experimental: D Tecadenoson Intervention: Drug: Tecadenoson Experimental: E Tecadenoson Intervention: Drug: Tecadenoson
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	21
Completion Date	July 2008
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00713401
Other Study ID Numbers ^ICMJE	CVT 4129
Has Data Monitoring Committee	No
Responsible Party	Philip Sager, Vice President, Clinical Research, Gilead Sciences
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Gilead Sciences
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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