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Safety Study of Tecadenoson to Treat Atrial Fibrillation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713401
First Posted: July 11, 2008
Last Update Posted: March 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
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).

Condition Intervention Phase
Atrial Fibrillation Drug: Tecadenoson Drug: Esmolol Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities [ Time Frame: Baseline to Day 7 ]

Secondary Outcome Measures:
  • Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram [ Time Frame: Baseline to Day 7 ]

Enrollment: 21
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion
Drug: Tecadenoson
Tecadenoson administered intravenously (i.v.)
Other Name: CVT-510
Drug: Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Other Name: Brevibloc®
Experimental: Cohort B
Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion
Drug: Tecadenoson
Tecadenoson administered intravenously (i.v.)
Other Name: CVT-510
Drug: Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Other Name: Brevibloc®
Experimental: Cohort C
Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion
Drug: Tecadenoson
Tecadenoson administered intravenously (i.v.)
Other Name: CVT-510
Drug: Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Other Name: Brevibloc®
Experimental: Cohort D
Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion
Drug: Tecadenoson
Tecadenoson administered intravenously (i.v.)
Other Name: CVT-510
Drug: Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Other Name: Brevibloc®
Experimental: Cohort E
Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion
Drug: Tecadenoson
Tecadenoson administered intravenously (i.v.)
Other Name: CVT-510
Drug: Esmolol
Esmolol low dose infusion according to manufacturer's instructions
Other Name: Brevibloc®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713401


Locations
United States, California
CV Therapeutics, Inc.
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00713401     History of Changes
Other Study ID Numbers: CVT 4129
First Submitted: July 9, 2008
First Posted: July 11, 2008
Last Update Posted: March 11, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Esmolol
Tecadenoson
Adenosine
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Vasodilator Agents