Safety Study of Tecadenoson to Treat Atrial Fibrillation

NCT ID: NCT00713401

Last Updated: 2014-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A

Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion

Group Type EXPERIMENTAL

Tecadenoson

Intervention Type DRUG

Tecadenoson administered intravenously (i.v.)

Esmolol

Intervention Type DRUG

Esmolol low dose infusion according to manufacturer's instructions

Cohort B

Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion

Group Type EXPERIMENTAL

Tecadenoson

Intervention Type DRUG

Tecadenoson administered intravenously (i.v.)

Esmolol

Intervention Type DRUG

Esmolol low dose infusion according to manufacturer's instructions

Cohort C

Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion

Group Type EXPERIMENTAL

Tecadenoson

Intervention Type DRUG

Tecadenoson administered intravenously (i.v.)

Esmolol

Intervention Type DRUG

Esmolol low dose infusion according to manufacturer's instructions

Cohort D

Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion

Group Type EXPERIMENTAL

Tecadenoson

Intervention Type DRUG

Tecadenoson administered intravenously (i.v.)

Esmolol

Intervention Type DRUG

Esmolol low dose infusion according to manufacturer's instructions

Cohort E

Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion

Group Type EXPERIMENTAL

Tecadenoson

Intervention Type DRUG

Tecadenoson administered intravenously (i.v.)

Esmolol

Intervention Type DRUG

Esmolol low dose infusion according to manufacturer's instructions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tecadenoson

Tecadenoson administered intravenously (i.v.)

Intervention Type DRUG

Esmolol

Esmolol low dose infusion according to manufacturer's instructions

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CVT-510 Brevibloc®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CV Therapeutics, Inc.

Palo Alto, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23989533 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CVT 4129

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Beta-Blocker Heart Attack Trial (BHAT)
NCT00000492 COMPLETED PHASE3