Back to resultsSafety Study of Tecadenoson to Treat Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tecadenoson
Esmolol
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility 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 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
Sites / Locations
- CV Therapeutics, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort A
Cohort B
Cohort C
Cohort D
Cohort E
Arm Description
Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion
Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion
Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion
Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion
Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion
Outcomes
Primary Outcome Measures
Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Secondary Outcome Measures
Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00713401
Brief Title
Safety Study of Tecadenoson to Treat Atrial Fibrillation
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion
Arm Title
Cohort D
Arm Type
Experimental
Arm Description
Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion
Arm Title
Cohort E
Arm Type
Experimental
Arm Description
Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion
Intervention Type
Drug
Intervention Name(s)
Tecadenoson
Other Intervention Name(s)
CVT-510
Intervention Description
Tecadenoson administered intravenously (i.v.)
Intervention Type
Drug
Intervention Name(s)
Esmolol
Other Intervention Name(s)
Brevibloc®
Intervention Description
Esmolol low dose infusion according to manufacturer's instructions
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Time Frame
Baseline to Day 7
Secondary Outcome Measure Information:
Title
Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram
Time Frame
Baseline to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
CV Therapeutics, Inc.
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23989533
Citation
Corino VD, Holmqvist F, Mainardi LT, Platonov PG. Beta-blockade and A1-adenosine receptor agonist effects on atrial fibrillatory rate and atrioventricular conduction in patients with atrial fibrillation. Europace. 2014 Apr;16(4):587-94. doi: 10.1093/europace/eut251. Epub 2013 Aug 29.
Results Reference
derived
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Safety Study of Tecadenoson to Treat Atrial Fibrillation
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