Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.

This study has been completed.

First Received: October 25, 2007 Last Updated: December 18, 2008 History of Changes

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00568945

Purpose

This trial has the primary goal to show that BAY 68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Capadenoson (BAY68-4986)	Phase II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation by Administration of Capadenoson in a Dose of 4 mg Once Daily for Five Days

Further study details as provided by Bayer:

Primary Outcome Measures:

The effect of capadenoson (BAY 68-4986) on rate control in patients with atrial fibrillation [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate safety and tolerability of this treatment with capadenoson [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	January 2008
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Capadenoson (BAY68-4986) 4 mg BAY 68-4986 for five days

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and/or female (without childbearing potential) white patients
History of persistent or permanent atrial fibrillation
18 to 75 years of age

Exclusion Criteria:

Patients with high-risk cardiovascular diseases
Stroke or myocardial infarction
Relevant pathological changes in the ECG or echocardiography
Medication affecting ventricular response in Afib

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568945

Locations

Germany, Thüringen

Erfurt, Thüringen, Germany, 99084

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12679, Eudract-No: 2007-003619-30
Study First Received:	October 25, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00568945 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Bayer:

Atrial Fibrillation
Capadenoson

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009