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OpenTrials
Completed

NCT Number: NCT00713401

Safety Study of Tecadenoson to Treat Atrial Fibrillation

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CV Therapeutics, Inc.

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tecadenoson

Drug

Tecadenoson administered intravenously (i.v.)

Other names: CVT-510

esmolol

Drug

Esmolol low dose infusion according to manufacturer's instructions

Other names: Brevibloc®

Primary outcomes

  1. Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities

    Time frame: Baseline to Day 7

Secondary outcomes

  1. Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram

    Time frame: Baseline to Day 7

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2008
Registry last updated
Mar 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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