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Safety Study of Tecadenoson to Treat Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00713401
First received: July 9, 2008
Last updated: March 23, 2011
Last verified: March 2011
History of Changes
  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
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Determine the tolerability and safety of tecadenoson. [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate effect of tecadenoson alone and in combination with esmolol on R-R interval and ventricular rate. [ Time Frame: 7 Day ] [ Designated as safety issue: No ]

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: A
Tecadenoson
 Drug: Tecadenoson
Period 1: 75 mcg, IV bolus. Period 2: 75 mcg, IV bolus + esmolol low dose infusion.
Other Name: CVT-510
Experimental: B
Tecadenoson
 Drug: Tecadenoson
Period 1: 150 mcg, IV bolus. Period 2: 150 mcg, IV bolus + esmolol low dose infusion.
Other Name: CVT-510
Experimental: C
Tecadenoson
 Drug: Tecadenoson
Period 1: 300 mcg, IV bolus. Period 2: 300 mcg, IV bolus + esmolol low dose infusion.
Other Name: CVT-510
Experimental: D
Tecadenoson
 Drug: Tecadenoson
Period 1: 75 mcg, IV bolus. Period 2: 75 mcg, IV bolus + esmolol high dose infusion.
Other Name: CVT-510
Experimental: E
Tecadenoson
 Drug: Tecadenoson
Period 1: 150 or 300 mcg, IV bolus. Period 2: 150 or 300 mcg, IV bolus + esmolol high dose infusion.
Other Name: CVT-510

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713401

Locations
United States, California
Multiple study locations (see Central Contact); CV Therapeutics, Inc.
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Philip Sager, Vice President, Clinical Research, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00713401     History of Changes
Other Study ID Numbers: CVT 4129
Study First Received: July 9, 2008
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013