check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

12679

ClinicalTrials.gov Identifier:

NCT00568945

EudraCT Number:

2007-003619-30

EU CT Number:

Not Available
Study to investigate the effect of the A1 agonist capadenoson on ventricular HR in patients with persistent or permanent atrial fibrillation.

Trial purpose

This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years
  • - Male and/or female (without childbearing potential) white patients
    - History of persistent or permanent atrial fibrillation
    - 18 to 75 years of age
  • - Patients with high-risk cardiovascular diseases
    - Stroke or myocardial infarction
    - Relevant pathological changes in the ECG or echocardiography
    - Medication affecting ventricular response in Afib

Trial summary

Enrollment Goal
28
Trial Dates
January 2008 - December 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Capadenoson (BAY68-4986)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
CardioSec Clinical Research GmbHErfurt, 99084, Germany

Primary Outcome

  • The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation
    date_rangeTime Frame:
    1 week
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • To investigate safety and tolerability of this treatment with capadenoson
    date_rangeTime Frame:
    2 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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