Safety Study of Tecadenoson to Treat Atrial Fibrillation - Full Text View

Sponsored by:	CV Therapeutics
Information provided by:	CV Therapeutics
ClinicalTrials.gov Identifier:	NCT00713401

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).

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Tecadenoson	Phase II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

Drug Information available for: Tecadenoson Esmolol Asl 8052

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
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)

Further study details as provided by CV Therapeutics:

Primary Outcome Measures:

Determine the tolerability and safety of tecadenoson. [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	21
Study Start Date:	February 2008
Study Completion Date:	July 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Tecadenoson	Drug: Tecadenoson Period 1: 75 mcg, IV bolus. Period 2: 75 mcg, IV bolus + esmolol low dose infusion.
B: Experimental Tecadenoson	Drug: Tecadenoson Period 1: 150 mcg, IV bolus. Period 2: 150 mcg, IV bolus + esmolol low dose infusion.
C: Experimental Tecadenoson	Drug: Tecadenoson Period 1: 300 mcg, IV bolus. Period 2: 300 mcg, IV bolus + esmolol low dose infusion.
D: Experimental Tecadenoson	Drug: Tecadenoson Period 1: 75 mcg, IV bolus. Period 2: 75 mcg, IV bolus + esmolol high dose infusion.
E: Experimental Tecadenoson	Drug: Tecadenoson Period 1: 150 or 300 mcg, IV bolus. Period 2: 150 or 300 mcg, IV bolus + esmolol high dose infusion.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713401

Locations

United States, California
Multiple study locations (see Central Contact); CV Therapeutics, Inc.
Palo Alto, California, United States, 94304

Sponsors and Collaborators

CV Therapeutics

More Information

CV Therapeutics, Inc. This link exits the ClinicalTrials.gov site

Responsible Party:	CV Therapeutics ( Carol D. Karp, Senior Vice President, Regulatory Affairs, Quality and Drug Safety )
Study ID Numbers:	CVT 4129
Study First Received:	July 9, 2008
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00713401
Health Authority:	United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation

Study placed in the following topic categories:

Heart Diseases
Esmolol
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009