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
  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
Endpoint Classification: Safety Study
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:


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 ] [ Designated as safety issue: No ]

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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713401

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

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00713401     History of Changes
Other Study ID Numbers: CVT 4129
Study First Received: July 9, 2008
Last Updated: February 10, 2014
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
Esmolol
Adenosine
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 23, 2014