Safety Study of Tecadenoson to Treat Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713401
• Other study ID #: CVT 4129
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2008
• Last updated: February 10, 2014
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: February 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Tecadenoson
Tecadenoson administered intravenously (i.v.)
• Esmolol
Esmolol low dose infusion according to manufacturer's instructions

Locations

Country	Name	City	State
United States	CV Therapeutics, Inc.	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities		Baseline to Day 7	No
Secondary	Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram		Baseline to Day 7	No