Back to resultsStudy to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Capadenoson (BAY68-4986)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Capadenoson
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation
Secondary Outcome Measures
To investigate safety and tolerability of this treatment with capadenoson
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568945
Brief Title
Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Capadenoson
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Capadenoson (BAY68-4986)
Intervention Description
4 mg BAY68-4986 for five days
Primary Outcome Measure Information:
Title
The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation
Time Frame
1 week
Secondary Outcome Measure Information:
Title
To investigate safety and tolerability of this treatment with capadenoson
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99084
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.
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