Safety Study of Tecadenoson to Treat Atrial Fibrillation
- Registration Number
- NCT00713401
- Lead Sponsor
- Gilead Sciences
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort B Tecadenoson Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion Cohort B Esmolol Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion Cohort A Tecadenoson Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion Cohort A Esmolol Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion Cohort C Esmolol Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion Cohort D Esmolol Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion Cohort E Esmolol Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion Cohort C Tecadenoson Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion Cohort D Tecadenoson Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion Cohort E Tecadenoson Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities Baseline to Day 7
- Secondary Outcome Measures
Name Time Method Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram Baseline to Day 7
Trial Locations
- Locations (1)
CV Therapeutics, Inc.
🇺🇸Palo Alto, California, United States