NCT00713401

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
Last Updated

March 11, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

July 9, 2008

Last Update Submit

February 10, 2014

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

    Baseline to Day 7

Secondary Outcomes (1)

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

    Baseline to Day 7

Study Arms (5)

Cohort A

EXPERIMENTAL

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

Drug: TecadenosonDrug: Esmolol

Cohort B

EXPERIMENTAL

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

Drug: TecadenosonDrug: Esmolol

Cohort C

EXPERIMENTAL

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

Drug: TecadenosonDrug: Esmolol

Cohort D

EXPERIMENTAL

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

Drug: TecadenosonDrug: Esmolol

Cohort E

EXPERIMENTAL

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

Drug: TecadenosonDrug: Esmolol

Interventions

TecadenosonDRUG

Tecadenoson administered intravenously (i.v.)

Also known as: CVT-510
Cohort ACohort BCohort CCohort DCohort E
EsmololDRUG

Esmolol low dose infusion according to manufacturer's instructions

Also known as: Brevibloc®
Cohort ACohort BCohort CCohort DCohort E

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CV Therapeutics, Inc.

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • 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.

    PMID: 23989533DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

tecadenosonesmolol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2008

Study Completion

July 1, 2008

Last Updated

March 11, 2014

Record last verified: 2014-02

Locations

US(1)