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Safety Study of Tecadenoson to Treat Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00713401
First received: July 9, 2008
Last updated: February 10, 2014
Last verified: February 2014

July 9, 2008
February 10, 2014
February 2008
April 2008   (final data collection date for primary outcome measure)
Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities [ Time Frame: Baseline to Day 7 ] [ Designated as safety issue: No ]
Determine the tolerability and safety of tecadenoson. [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00713401 on ClinicalTrials.gov Archive Site
Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram [ Time Frame: Baseline to Day 7 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Safety Study of Tecadenoson to Treat Atrial Fibrillation
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • 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 A
    Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion
    Interventions:
    • Drug: Tecadenoson
    • Drug: Esmolol
  • Experimental: Cohort B
    Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion
    Interventions:
    • Drug: Tecadenoson
    • Drug: Esmolol
  • Experimental: Cohort C
    Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion
    Interventions:
    • Drug: Tecadenoson
    • Drug: Esmolol
  • Experimental: Cohort D
    Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion
    Interventions:
    • Drug: Tecadenoson
    • Drug: Esmolol
  • 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
    Interventions:
    • Drug: Tecadenoson
    • Drug: Esmolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00713401
CVT 4129
No
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP